Trial Outcomes & Findings for A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) (NCT NCT05088460)

NCT ID: NCT05088460

Last Updated: 2025-10-16

Results Overview

Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (\> 200 mg/dL) and with baseline leptin \< 8.0 ng/mL (Cohort A).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline to week 12
• Results posted on: 2025-10-16

Participant Flow

A total of 66 participants were screened, of whom 20 were randomized and received study treatment.

Participant milestones

Measure	Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Overall Study STARTED	6	6	4	4
Overall Study Completed Treatment During DBTP	5	6	4	4
Overall Study Completed Treatment During SBTP	5	5	3	4
Overall Study COMPLETED	6	6	4	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

Baseline characteristics by cohort

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Cohort B: Placebo to REGN4461 n=4 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort B: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Total n=20 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 16.79 • n=5 Participants	43.8 years STANDARD_DEVIATION 13.47 • n=7 Participants	48.0 years STANDARD_DEVIATION 11.97 • n=5 Participants	40.3 years STANDARD_DEVIATION 12.82 • n=4 Participants	43.0 years STANDARD_DEVIATION 13.40 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Fasting Triglycerides Serum Concentration	1100.9 milligrams per deciliter (mg/dL) n=5 Participants	737.8 milligrams per deciliter (mg/dL) n=7 Participants	675.0 milligrams per deciliter (mg/dL) n=5 Participants	336.2 milligrams per deciliter (mg/dL) n=4 Participants	698.3 milligrams per deciliter (mg/dL) n=21 Participants
Hemoglobin A1c (HbA1c)	8.8 percentage of glycated hemoglobin STANDARD_DEVIATION 1.62 • n=5 Participants	8.2 percentage of glycated hemoglobin STANDARD_DEVIATION 1.76 • n=7 Participants	6.9 percentage of glycated hemoglobin STANDARD_DEVIATION 0.91 • n=5 Participants	8.6 percentage of glycated hemoglobin STANDARD_DEVIATION 2.06 • n=4 Participants	8.2 percentage of glycated hemoglobin STANDARD_DEVIATION 1.68 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to week 12

Population: The Full Analysis Set (FAS) included all randomized participants who received any study drug in the double-blind treatment period (DBTP) and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (> 200 mg/dL) and with baseline leptin < 8.0 ng/mL (Cohort A).

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=5 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)	-11.30 percent change Standard Deviation 46.306	-38.97 percent change Standard Deviation 16.998	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline to week 12

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Change in HbA1c was reported for participants with elevated baseline HbA1c (> 7.0%) and with baseline leptin < 8.0 ng/mL (Cohort A).

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=4 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=5 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)	-0.05 percentage of glycated hemoglobin Standard Deviation 0.451	-1.08 percentage of glycated hemoglobin Standard Deviation 1.108	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (>200 mg/dL) in Cohort B and Cohorts A + B.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=4 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=9 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)	36.78 percent change Standard Deviation 44.863	-35.59 percent change Standard Deviation 8.754	10.07 percent change Standard Deviation 49.689	-37.62 percent change Standard Deviation 13.752	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Change in HbA1c was reported for participants with elevated baseline HbA1c (>7.0%) in Cohort B and Cohorts A + B.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=2 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=3 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=6 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=8 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)	-0.20 percentage of glycated hemoglobin Standard Deviation 0.283	-0.90 percentage of glycated hemoglobin Standard Deviation 0.964	-0.10 percentage of glycated hemoglobin Standard Deviation 0.379	-1.01 percentage of glycated hemoglobin Standard Deviation 0.988	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Percent change in fasting serum TG was reported for participants in Study Arm 1.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=5 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=9 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1) Week 12	-11.30 percent change Standard Deviation 46.306	36.78 percent change Standard Deviation 44.863	10.07 percent change Standard Deviation 49.689	—	—	—	—	—	—	—	—	—
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1) Week 24	-29.79 percent change Standard Deviation 35.109	-8.96 percent change Standard Deviation 13.673	-23.84 percent change Standard Deviation 30.923	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Percent change in fasting serum TG was reported for participants in Study Arm 2.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2) Week 12	-38.97 percent change Standard Deviation 16.998	-35.59 percent change Standard Deviation 8.754	-37.62 percent change Standard Deviation 13.752	—	—	—	—	—	—	—	—	—
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2) Week 24	-30.77 percent change Standard Deviation 48.883	-5.30 percent change Standard Deviation 51.158	-18.04 percent change Standard Deviation 48.282	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Change from baseline in HbA1c was reported for participants in Study Arm 1.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=5 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=9 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1) Week 12	-0.10 percentage of glycated hemoglobin Standard Deviation 0.406	0.13 percentage of glycated hemoglobin Standard Deviation 0.427	0.00 percentage of glycated hemoglobin Standard Deviation 0.406	—	—	—	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1) Week 24	-0.78 percentage of glycated hemoglobin Standard Deviation 0.694	0.13 percentage of glycated hemoglobin Standard Deviation 0.802	-0.44 percentage of glycated hemoglobin Standard Deviation 0.826	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Change from baseline in HbA1c was reported for participants in Study Arm 2.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2) Week 12	-0.92 percentage of glycated hemoglobin Standard Deviation 1.068	-0.78 percentage of glycated hemoglobin Standard Deviation 0.826	-0.86 percentage of glycated hemoglobin Standard Deviation 0.931	—	—	—	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2) Week 24	-0.98 percentage of glycated hemoglobin Standard Deviation 1.357	-0.50 percentage of glycated hemoglobin Standard Deviation 1.068	-0.77 percentage of glycated hemoglobin Standard Deviation 1.188	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Change from baseline in fasting glucose was reported for participants in Study Arm 1.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=5 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=9 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1) Week 12	4.8 milligrams per deciliter (mg/dL) Standard Deviation 29.55	0.0 milligrams per deciliter (mg/dL) Standard Deviation 60.37	2.7 milligrams per deciliter (mg/dL) Standard Deviation 42.54	—	—	—	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1) Week 24	7.2 milligrams per deciliter (mg/dL) Standard Deviation 29.65	-15.5 milligrams per deciliter (mg/dL) Standard Deviation 6.36	0.7 milligrams per deciliter (mg/dL) Standard Deviation 26.75	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Change from baseline in fasting glucose was reported for participants in Study Arm 2.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2) Week 12	-5.2 mg/dL Standard Deviation 36.55	-19.5 mg/dL Standard Deviation 22.87	-10.9 mg/dL Standard Deviation 31.17	—	—	—	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2) Week 24	1.8 mg/dL Standard Deviation 26.35	-12.3 mg/dL Standard Deviation 58.59	-5.3 mg/dL Standard Deviation 42.71	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.

Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=3 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=2 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=5 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1) Week 12	-11.44 percent change Standard Deviation 18.576	-0.74 percent change Standard Deviation 9.919	-7.16 percent change Standard Deviation 15.214	—	—	—	—	—	—	—	—	—
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1) Week 24	-47.21 percent change Standard Deviation 22.176	44.81 percent change Standard Deviation NA SD not calculable with n=1	-16.54 percent change Standard Deviation 55.394	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.

Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=4 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=8 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2) Week 12	-17.05 percent change Standard Deviation 25.788	-18.80 percent change Standard Deviation 17.300	-17.92 percent change Standard Deviation 20.351	—	—	—	—	—	—	—	—	—
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2) Week 24	-24.33 percent change Standard Deviation 27.151	-19.53 percent change Standard Deviation 19.324	-22.27 percent change Standard Deviation 22.353	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=4 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=4 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score Week 24	-0.330 score on a scale Standard Deviation 0.3684	-0.018 score on a scale Standard Deviation 0.6228	-0.383 score on a scale Standard Deviation 0.1550	-0.285 score on a scale Standard Deviation 0.6180	-0.350 score on a scale Standard Deviation 0.2919	-0.137 score on a scale Standard Deviation 0.5975	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score Week 12	-0.060 score on a scale Standard Deviation 0.9009	-0.538 score on a scale Standard Deviation 0.4679	-0.240 score on a scale Standard Deviation 0.2483	-0.415 score on a scale Standard Deviation 0.7539	-0.132 score on a scale Standard Deviation 0.6929	-0.489 score on a scale Standard Deviation 0.5614	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=4 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=4 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score Week 12	0.185 score on a scale Standard Deviation 0.8013	-0.475 score on a scale Standard Deviation 0.4630	-0.338 score on a scale Standard Deviation 0.4287	-0.173 score on a scale Standard Deviation 0.3625	-0.024 score on a scale Standard Deviation 0.7006	-0.354 score on a scale Standard Deviation 0.4328	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score Week 24	-0.128 score on a scale Standard Deviation 0.0622	0.046 score on a scale Standard Deviation 0.6776	-0.103 score on a scale Standard Deviation 0.2230	0.308 score on a scale Standard Deviation 0.9603	-0.119 score on a scale Standard Deviation 0.1288	0.162 score on a scale Standard Deviation 0.7710	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=4 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=4 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score Week 12	0.248 score on a scale Standard Deviation 0.8642	-0.550 score on a scale Standard Deviation 0.5334	-0.168 score on a scale Standard Deviation 0.2900	0.008 score on a scale Standard Deviation 0.9139	0.082 score on a scale Standard Deviation 0.6993	-0.327 score on a scale Standard Deviation 0.7206	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score Week 24	0.016 score on a scale Standard Deviation 0.3932	0.120 score on a scale Standard Deviation 0.4374	-0.183 score on a scale Standard Deviation 0.0603	-0.138 score on a scale Standard Deviation 0.6595	-0.059 score on a scale Standard Deviation 0.3163	0.006 score on a scale Standard Deviation 0.5265	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=4 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=4 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score Week 12	0.063 score on a scale Standard Deviation 1.1988	-0.267 score on a scale Standard Deviation 0.5381	-1.180 score on a scale Standard Deviation 0.3764	-0.535 score on a scale Standard Deviation 0.5736	-0.434 score on a scale Standard Deviation 1.1216	-0.374 score on a scale Standard Deviation 0.5383	—	—	—	—	—	—
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score Week 24	-0.182 score on a scale Standard Deviation 0.6474	0.012 score on a scale Standard Deviation 0.6474	-1.193 score on a scale Standard Deviation 0.6630	-0.178 score on a scale Standard Deviation 0.8032	-0.561 score on a scale Standard Deviation 0.7994	-0.072 score on a scale Standard Deviation 0.6793	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: The DB SAF included all participants who received any double-blind study drug in DBTP. The single-blind safety analysis set (SB SAF) included all randomized participants who received any single-blind study drug in the single-blind treatment period (SBTP).

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=6 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=4 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=4 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=10 Participants "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 n=5 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 n=6 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 n=3 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 n=4 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 n=8 Participants SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 n=10 Participants SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	4 Participants	5 Participants	4 Participants	4 Participants	8 Participants	9 Participants	3 Participants	5 Participants	3 Participants	4 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.

Population: The PK analysis set was defined as all randomized participants who received any study drug and have at least 1 non-missing measurement of REGN4461 concentration following the first dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=10 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=10 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Concentrations of REGN4461 in Serum Week 36 (pre-dose)	0.0110 milligrams per liter (mg/L) Standard Deviation 0.0330	0.0373 milligrams per liter (mg/L) Standard Deviation 0.0788	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 0 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	0 milligrams per liter (mg/L) Standard Deviation 0	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 0 (post-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	232 milligrams per liter (mg/L) Standard Deviation 83.8	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 1 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	64.3 milligrams per liter (mg/L) Standard Deviation 24.9	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 2 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	52.5 milligrams per liter (mg/L) Standard Deviation 13.3	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 3 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	60.2 milligrams per liter (mg/L) Standard Deviation 19.0	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 4 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	58.8 milligrams per liter (mg/L) Standard Deviation 23.8	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 5 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	62.0 milligrams per liter (mg/L) Standard Deviation 36.1	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 6 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	68.8 milligrams per liter (mg/L) Standard Deviation 38.8	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 9 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	79.6 milligrams per liter (mg/L) Standard Deviation 49.2	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 12 (pre-dose)	0 milligrams per liter (mg/L) Standard Deviation 0	87.1 milligrams per liter (mg/L) Standard Deviation 57.8	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 12 (post-dose)	252 milligrams per liter (mg/L) Standard Deviation 50.7	87.6 milligrams per liter (mg/L) Standard Deviation 49.7	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 13 (pre-dose)	62.4 milligrams per liter (mg/L) Standard Deviation 17.5	97.6 milligrams per liter (mg/L) Standard Deviation 68.6	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 14 (pre-dose)	56.6 milligrams per liter (mg/L) Standard Deviation 17.6	92.8 milligrams per liter (mg/L) Standard Deviation 68.0	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 15 (pre-dose)	64.2 milligrams per liter (mg/L) Standard Deviation 29.6	90.5 milligrams per liter (mg/L) Standard Deviation 59.1	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 16 (pre-dose)	68.8 milligrams per liter (mg/L) Standard Deviation 24.3	103 milligrams per liter (mg/L) Standard Deviation 76.4	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 17 (pre-dose)	73.4 milligrams per liter (mg/L) Standard Deviation 30.8	92.1 milligrams per liter (mg/L) Standard Deviation 73.3	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 18 (pre-dose)	75.1 milligrams per liter (mg/L) Standard Deviation 27.1	95.0 milligrams per liter (mg/L) Standard Deviation 79.3	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 21 (pre-dose)	89.3 milligrams per liter (mg/L) Standard Deviation 40.0	72.9 milligrams per liter (mg/L) Standard Deviation 51.4	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 28 (pre-dose)	10.9 milligrams per liter (mg/L) Standard Deviation 12.0	16.0 milligrams per liter (mg/L) Standard Deviation 23.4	—	—	—	—	—	—	—	—	—	—
Concentrations of REGN4461 in Serum Week 32 (pre-dose)	0.0663 milligrams per liter (mg/L) Standard Deviation 0.0705	0.189 milligrams per liter (mg/L) Standard Deviation 0.281	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 281

Population: The ADA analysis set included all treated participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose of study drug.

Outcome measures

Measure	Arm 1 Cohort A: Placebo to REGN4461 n=10 Participants Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	Arm 2 Cohort A: REGN4461 to REGN4461 n=10 Participants Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	Arm 1 Combined Cohort A + B: Placebo to REGN4461 "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 "Arm 2 Cohort A" and "Arm 2 Cohort B" combined	SBTP Arm 1 Cohort A: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461 SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined	SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—

Adverse Events

DBTP Arm 1 Cohort A: Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

DBTP Arm 2 Cohort A: REGN4461

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

DBTP Arm 1 Cohort B: Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

DBTP Arm 2 Cohort B: REGN4461

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

SBTP Arm 1 Cohort A: Placebo to REGN4461

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

SBTP Arm 2 Cohort A: REGN4461 to REGN4461

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

SBTP Arm 1 Cohort B: Placebo to REGN4461

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SBTP Arm 2 Cohort B: REGN4461 to REGN4461

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	DBTP Arm 1 Cohort A: Placebo n=6 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.	DBTP Arm 2 Cohort A: REGN4461 n=6 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.	DBTP Arm 1 Cohort B: Placebo n=4 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.	DBTP Arm 2 Cohort B: REGN4461 n=4 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.	SBTP Arm 1 Cohort A: Placebo to REGN4461 n=5 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 n=6 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 n=3 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 n=4 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Gastrointestinal disorders Pancreatitis acute	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Cardiac disorders Angina pectoris	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Vascular disorders Hypertension	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)

Other adverse events

Measure	DBTP Arm 1 Cohort A: Placebo n=6 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.	DBTP Arm 2 Cohort A: REGN4461 n=6 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.	DBTP Arm 1 Cohort B: Placebo n=4 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.	DBTP Arm 2 Cohort B: REGN4461 n=4 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.	SBTP Arm 1 Cohort A: Placebo to REGN4461 n=5 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort A: REGN4461 to REGN4461 n=6 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.	SBTP Arm 1 Cohort B: Placebo to REGN4461 n=3 participants at risk Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.	SBTP Arm 2 Cohort B: REGN4461 to REGN4461 n=4 participants at risk Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Infections and infestations Influenza	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Bacterial infection	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations COVID-19	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	50.0% 2/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Gastroenteritis viral	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Oral candidiasis	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Pharyngitis streptococcal	16.7% 1/6 • Number of events 3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Bronchitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Cellulitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Diverticulitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Fungal infection	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Nasopharyngitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Onychomycosis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Oral herpes	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Otitis externa	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Otitis media	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Paronychia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Pneumonia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Respiratory syncytial virus infection	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Sinusitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	75.0% 3/4 • Number of events 4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Tooth infection	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	50.0% 3/6 • Number of events 3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	50.0% 2/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Urinary tract infection	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	40.0% 2/5 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Infections and infestations Vulvovaginal candidiasis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	66.7% 2/3 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	50.0% 2/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Ascites	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Constipation	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Dry mouth	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Duodenal ulcer	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Gastritis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Nausea	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Plicated tongue	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Retching	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Stomatitis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Gastrointestinal disorders Varices oesophageal	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 2/6 • Number of events 4 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Brain fog	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Carpal tunnel syndrome	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Cognitive disorder	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Dizziness	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	50.0% 3/6 • Number of events 3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Headache	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Lethargy	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Migraine	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Mononeuropathy	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Neuralgia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Presyncope	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Nervous system disorders Restless legs syndrome	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Psychiatric disorders Affect lability	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Psychiatric disorders Bipolar I disorder	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Psychiatric disorders Poor quality sleep	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Psychiatric disorders Suicidal ideation	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Ear and labyrinth disorders Vertigo	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Fatigue	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Peripheral swelling	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Asthenia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Chest discomfort	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Chills	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Decreased appetite	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Infusion site extravasation	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Injection site reaction	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 10 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Non-cardiac chest pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Oedema peripheral	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
General disorders Pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	50.0% 2/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)
Injury, poisoning and procedural complications Arterial injury	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 1/3 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	50.0% 2/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Blood pressure increased	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Carbohydrate antigen 19-9 increased	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Electrocardiogram abnormal	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Gamma-glutamyltransferase increased	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Investigations Haematocrit increased	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	40.0% 2/5 • Number of events 3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Hyperphagia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	33.3% 2/6 • Number of events 4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Metabolism and nutrition disorders Increased appetite	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Blood and lymphatic system disorders Splenomegaly	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Cardiac disorders Bundle branch block left	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Cardiac disorders Cardiac failure	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Cardiac disorders Defect conduction intraventricular	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Cardiac disorders Left ventricular hypertrophy	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Congenital, familial and genetic disorders Muscular dystrophy	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Eye disorders Photophobia	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)
Renal and urinary disorders Haematuria	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	25.0% 1/4 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Reproductive system and breast disorders Vaginal cyst	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	20.0% 1/5 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Vascular disorders Hypertension	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 1 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)
Vascular disorders Hypotension	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/6 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)	0.00% 0/5 • From signing of informed consent up to day 281 (end of study)	16.7% 1/6 • Number of events 2 • From signing of informed consent up to day 281 (end of study)	0.00% 0/3 • From signing of informed consent up to day 281 (end of study)	0.00% 0/4 • From signing of informed consent up to day 281 (end of study)

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER