Trial Outcomes & Findings for A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities (NCT NCT05051579)

Last Updated: 2023-09-13

Results Overview

Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

272 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2023-09-13

Participant Flow

For maintenance doses of LY3502970: 12, 24, 36, and 45 milligram (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose-escalation varied by dose group where the target maintenance dose was achieved between Weeks 5 and 16.

Participant milestones

Participant milestones
Measure	12 mg LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -1 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -2 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -1 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -2 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Placebo Participants received placebo administered orally once daily until 36 weeks.
Overall Study STARTED	50	53	29	29	31	30	50
Overall Study COMPLETED	44	46	27	24	23	28	43
Overall Study NOT COMPLETED	6	7	2	5	8	2	7

Reasons for withdrawal

Reasons for withdrawal
Measure	12 mg LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -1 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -2 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -1 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -2 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Placebo Participants received placebo administered orally once daily until 36 weeks.
Overall Study Sponsor Decision	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	3	5	2	1	4	0	4
Overall Study Lost to Follow-up	1	0	0	0	1	0	1
Overall Study Subject Unable to Visit Due to Working Out of Town	0	0	0	0	0	0	1
Overall Study Adverse Event	2	1	0	4	1	2	0
Overall Study Inadvertent Enrollment	0	0	0	0	0	0	1
Overall Study Subject Could not Tolerate Investigational Product (IP) and was Taken Off	0	1	0	0	0	0	0
Overall Study Patient was Initially Long Term Follow-up But Contacted and came to Site After Follow-up	0	0	0	0	1	0	0

Baseline Characteristics

A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	12 mg LY3502970 n=50 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=53 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -1 LY3502970 n=29 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	36 mg -2 LY3502970 n=29 Participants Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -1 LY3502970 n=31 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	45 mg -2 LY3502970 n=30 Participants Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Placebo n=50 Participants Participants received placebo administered orally once daily until 36 weeks.	Total n=272 Participants Total of all reporting groups
Age, Continuous	49.80 years STANDARD_DEVIATION 10.51 • n=5 Participants	57.00 years STANDARD_DEVIATION 9.09 • n=7 Participants	56.30 years STANDARD_DEVIATION 11.83 • n=5 Participants	55.40 years STANDARD_DEVIATION 10.93 • n=4 Participants	56.50 years STANDARD_DEVIATION 10.74 • n=21 Participants	50.90 years STANDARD_DEVIATION 12.58 • n=8 Participants	54.00 years STANDARD_DEVIATION 8.82 • n=8 Participants	54.20 years STANDARD_DEVIATION 10.67 • n=24 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	19 Participants n=21 Participants	16 Participants n=8 Participants	29 Participants n=8 Participants	161 Participants n=24 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	23 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	14 Participants n=8 Participants	21 Participants n=8 Participants	111 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=8 Participants	5 Participants n=8 Participants	39 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	46 Participants n=7 Participants	23 Participants n=5 Participants	26 Participants n=4 Participants	25 Participants n=21 Participants	22 Participants n=8 Participants	43 Participants n=8 Participants	223 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	10 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Asian	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	0 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	19 Participants n=24 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	46 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	29 Participants n=21 Participants	30 Participants n=8 Participants	45 Participants n=8 Participants	247 Participants n=24 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	0 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants
Race (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	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Region of Enrollment Canada	9 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	48 Participants n=24 Participants
Region of Enrollment Hungary	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	31 Participants n=24 Participants
Region of Enrollment United States	35 Participants n=5 Participants	37 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	19 Participants n=21 Participants	22 Participants n=8 Participants	39 Participants n=8 Participants	193 Participants n=24 Participants
Baseline Body Weight	107.49 Kilograms (kg) STANDARD_DEVIATION 25.34 • n=5 Participants	112.05 Kilograms (kg) STANDARD_DEVIATION 30.18 • n=7 Participants	107.78 Kilograms (kg) STANDARD_DEVIATION 22.45 • n=5 Participants	108.84 Kilograms (kg) STANDARD_DEVIATION 28.52 • n=4 Participants	105.23 Kilograms (kg) STANDARD_DEVIATION 20.40 • n=21 Participants	110.85 Kilograms (kg) STANDARD_DEVIATION 28.11 • n=8 Participants	107.57 Kilograms (kg) STANDARD_DEVIATION 25.24 • n=8 Participants	108.68 Kilograms (kg) STANDARD_DEVIATION 26.03 • n=24 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percent Change From Baseline in Body Weight in LY3502970 and Placebo	-8.6 Percent change Standard Error 0.85	-11.2 Percent change Standard Error 0.82	-12.3 Percent change Standard Error 0.77	-12.6 Percent change Standard Error 0.75	-2.0 Percent change Standard Error 0.81

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percent Change From Baseline in Body Weight in LY3502970 and Placebo	-9.4 Percent change Standard Error 1.05	-12.5 Percent change Standard Error 1.01	-13.5 Percent change Standard Error 0.95	-14.7 Percent change Standard Error 0.94	-2.3 Percent change Standard Error 1.00

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in Body Weight in LY3502970 and Placebo	-9.0 kg Standard Error 0.90	-12.3 kg Standard Error 0.86	-12.9 kg Standard Error 0.82	-13.3 kg Standard Error 0.79	-2.1 kg Standard Error 0.86

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in Body Weight in LY3502970 and Placebo	-9.8 kg Standard Error 1.10	-13.6 kg Standard Error 1.06	-14.2 kg Standard Error 1.00	-15.4 kg Standard Error 0.98	-2.4 kg Standard Error 1.05

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=43 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=49 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=52 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in Waist Circumference in LY3502970 and Placebo	-8.0 centimeter (cm) Standard Error 1.03	-8.8 centimeter (cm) Standard Error 1.00	-10.1 centimeter (cm) Standard Error 0.94	-12.2 centimeter (cm) Standard Error 0.93	-3.6 centimeter (cm) Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=43 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=49 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=52 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in Waist Circumference in LY3502970 and Placebo	-9.6 cm Standard Error 1.18	-11.2 cm Standard Error 1.15	-10.6 cm Standard Error 1.06	-13.6 cm Standard Error 1.07	-4.0 cm Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in BMI in LY3502970 and Placebo	-3.2 kilograms per meter square (kg/m^2) Standard Error 0.31	-4.2 kilograms per meter square (kg/m^2) Standard Error 0.30	-4.6 kilograms per meter square (kg/m^2) Standard Error 0.28	-4.7 kilograms per meter square (kg/m^2) Standard Error 0.27	-0.8 kilograms per meter square (kg/m^2) Standard Error 0.29

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Change From Baseline in BMI in LY3502970 and Placebo	-3.4 kg/m^2 Standard Error 0.38	-4.7 kg/m^2 Standard Error 0.36	-5.0 kg/m^2 Standard Error 0.34	-5.5 kg/m^2 Standard Error 0.34	-0.9 kg/m^2 Standard Error 0.36

SECONDARY outcome

Timeframe: Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.

Percentage of participants with \>=5% body weight loss was reported.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percentage of Participants With >=5% Body Weight Loss	74.39 percentage of participants	88.84 percentage of participants	89.46 percentage of participants	87.26 percentage of participants	22.88 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.

Percentage of participants with \>=10% body weight loss was reported.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percentage of Participants With >=10% Body Weight Loss	39.39 percentage of participants	56.61 percentage of participants	71.30 percentage of participants	69.86 percentage of participants	2.25 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.

Percentage of participants with \>=5% body weight loss was reported.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percentage of Participants With >=5% Body Weight Loss	72.00 percentage of participants	89.47 percentage of participants	92.05 percentage of participants	90.44 percentage of participants	24.02 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.

Percentage of participants with \>=10% body weight loss was reported.

Outcome measures

Outcome measures
Measure	12 mg LY3502970 n=44 Participants Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=51 Participants Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 mg LY3502970 n=56 Participants Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	45 mg LY3502970 n=57 Participants Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Placebo n=48 Participants Participants received placebo administered orally once daily until 36 weeks.
Percentage of Participants With >=10% Body Weight Loss	46.50 percentage of participants	61.88 percentage of participants	74.75 percentage of participants	69.07 percentage of participants	8.85 percentage of participants

Adverse Events

12 mg LY3502970

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

24 mg LY3502970

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

36 Mg-1 LY3502970

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

36 Mg-2 LY3502970

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

45 Mg-1 LY3502970

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

45 Mg-2 LY3502970

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	12 mg LY3502970 n=50 participants at risk Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=53 participants at risk Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 Mg-1 LY3502970 n=29 participants at risk Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	36 Mg-2 LY3502970 n=29 participants at risk Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	45 Mg-1 LY3502970 n=31 participants at risk Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	45 Mg-2 LY3502970 n=30 participants at risk Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Placebo n=50 participants at risk Participants received placebo administered orally once daily until 36 weeks.
Cardiac disorders Coronary artery disease	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal vein thrombosis	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreoretinal traction syndrome	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	12 mg LY3502970 n=50 participants at risk Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	24 mg LY3502970 n=53 participants at risk Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	36 Mg-1 LY3502970 n=29 participants at risk Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	36 Mg-2 LY3502970 n=29 participants at risk Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	45 Mg-1 LY3502970 n=31 participants at risk Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	45 Mg-2 LY3502970 n=30 participants at risk Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Placebo n=50 participants at risk Participants received placebo administered orally once daily until 36 weeks.
Cardiac disorders Atrioventricular block first degree	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 3/30 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 4/53 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.9% 4/31 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 4/53 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	8.0% 4/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 4/53 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.5% 2/31 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 1/30 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 2/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 3/30 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	24.0% 12/50 • Number of events 16 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	32.1% 17/53 • Number of events 21 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.6% 8/29 • Number of events 8 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.1% 7/29 • Number of events 10 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.4% 6/31 • Number of events 8 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 4/30 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.0% 3/50 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	24.0% 12/50 • Number of events 23 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	35.8% 19/53 • Number of events 29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 4/29 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.1% 5/31 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 10/30 • Number of events 16 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 5/50 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	16.0% 8/50 • Number of events 11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 4/53 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.7% 3/31 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.0% 3/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Eructation	18.0% 9/50 • Number of events 15 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.8% 11/53 • Number of events 14 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	17.2% 5/29 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.5% 2/31 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 6/30 • Number of events 9 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Flatulence	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 2/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.0% 4/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 5/53 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 4/29 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.9% 4/31 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	50.0% 25/50 • Number of events 39 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	58.5% 31/53 • Number of events 50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	41.4% 12/29 • Number of events 18 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	48.3% 14/29 • Number of events 18 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	41.9% 13/31 • Number of events 28 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.7% 11/30 • Number of events 23 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 5/50 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	26.0% 13/50 • Number of events 23 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	32.1% 17/53 • Number of events 33 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.6% 8/29 • Number of events 11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 4/29 • Number of events 9 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	29.0% 9/31 • Number of events 14 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 8/30 • Number of events 15 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.0% 3/50 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.5% 2/31 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	4.0% 2/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.2% 7/53 • Number of events 8 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 4/29 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.9% 4/31 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 4/30 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Covid-19	18.0% 9/50 • Number of events 11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	17.0% 9/53 • Number of events 9 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 4/29 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.1% 7/29 • Number of events 7 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.1% 5/31 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 5/30 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.0% 9/50 • Number of events 9 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	2.0% 1/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	6.0% 3/50 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	4.0% 2/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 3/53 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.0% 3/50 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	8.0% 4/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 4/53 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.7% 3/31 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 5/53 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 4/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	10.0% 5/50 • Number of events 5 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 2/53 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.5% 2/31 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 4/30 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	8.0% 4/50 • Number of events 4 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.1% 8/53 • Number of events 11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.9% 4/31 • Number of events 6 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 2/30 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 5/50 • Number of events 7 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/19 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/23 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/14 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Erectile dysfunction	5.3% 1/19 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/23 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/14 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/16 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.7% 3/31 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/30 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.0% 1/50 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/53 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 3/30 • Number of events 3 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 38 (36 weeks with 2 weeks safety follow up) All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60