Trial Outcomes & Findings for Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants (NCT NCT05046132)

NCT ID: NCT05046132

Last Updated: 2024-05-03

Results Overview

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 77 participants
• Primary outcome timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose
• Results posted on: 2024-05-03

Participant Flow

77 healthy participants aged 18 to 50 years, inclusive, were enrolled in the United States.

Participants were randomized 1:1:1 into Group 1, 2, or 3.

Participant milestones

Measure	Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin Participants received titrated doses of 2-7 milligrams (mg) setmelanotide once daily by subcutaneous (SC) injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16.	Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16.	Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16
Overall Study STARTED	28	24	25
Overall Study Received 2 mg Setmelanotide	28	0	0
Overall Study Received 3 mg Setmelanotide	24	0	0
Overall Study Received 5 mg Setmelanotide	23	0	0
Overall Study Received 7 mg Setmelanotide	21	0	0
Overall Study COMPLETED	21	23	25
Overall Study NOT COMPLETED	7	1	0

Reasons for withdrawal

Measure	Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin Participants received titrated doses of 2-7 milligrams (mg) setmelanotide once daily by subcutaneous (SC) injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16.	Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16.	Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16
Overall Study Adverse Event	4	0	0
Overall Study Withdrawal by Subject	3	0	0
Overall Study Positive Covid19 Result.	0	1	0

Baseline Characteristics

Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants

Baseline characteristics by cohort

Measure	Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin n=28 Participants Participants received titrated doses of 2-7 mg setmelanotide once daily by SC injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16.	Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin n=24 Participants Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16.	Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg n=25 Participants Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16.	Total n=77 Participants Total of all reporting groups
Age, Continuous	31.9 years STANDARD_DEVIATION 6.47 • n=5 Participants	36.1 years STANDARD_DEVIATION 9.28 • n=7 Participants	34.8 years STANDARD_DEVIATION 8.60 • n=5 Participants	34.2 years STANDARD_DEVIATION 8.22 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 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
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose

Population: Pharmacokinetic (PK)/QTc Population included participants who were in both ECG \& PK populations. PK Population included all participants who received at least 1 dose of setmelanotide or moxifloxacin \& have at least 1 quantifiable concentration of setmelanotide or moxifloxacin. ECG Population included all participants in safety population with measurements at baseline as well as on-treatment with at least one post-dose timepoint with a valid value. Participants with available data were reported.

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant.

QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=25 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 Predose	1.9 milliseconds (msec) Standard Deviation 7.82	-1.5 milliseconds (msec) Standard Deviation 5.25
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 0.5 hr Post dose	-3.6 milliseconds (msec) Standard Deviation 9.83	-3.5 milliseconds (msec) Standard Deviation 8.16
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 1 hr Post dose	-2.9 milliseconds (msec) Standard Deviation 12.69	-3.5 milliseconds (msec) Standard Deviation 5.87
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 1.5 hr Post dose	-3.0 milliseconds (msec) Standard Deviation 9.53	-3.2 milliseconds (msec) Standard Deviation 7.44
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 2 hr Post dose	-1.0 milliseconds (msec) Standard Deviation 11.26	-3.4 milliseconds (msec) Standard Deviation 5.70
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 2.5 hr Post dose	1.2 milliseconds (msec) Standard Deviation 11.22	-2.0 milliseconds (msec) Standard Deviation 8.92
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 3 hr Post dose	2.1 milliseconds (msec) Standard Deviation 10.06	-2.6 milliseconds (msec) Standard Deviation 6.75
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 4 hr Post dose	2.0 milliseconds (msec) Standard Deviation 9.76	-2.4 milliseconds (msec) Standard Deviation 8.09
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 5 hr Post dose	2.4 milliseconds (msec) Standard Deviation 9.38	0.2 milliseconds (msec) Standard Deviation 8.99
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 6 hr Post dose	-0.4 milliseconds (msec) Standard Deviation 9.71	-1.8 milliseconds (msec) Standard Deviation 6.88
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 7 hr Post dose	1.0 milliseconds (msec) Standard Deviation 8.02	-1.3 milliseconds (msec) Standard Deviation 7.36
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 8 hr Post dose	2.6 milliseconds (msec) Standard Deviation 9.11	-0.3 milliseconds (msec) Standard Deviation 7.93
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 9 hr Post dose	4.1 milliseconds (msec) Standard Deviation 7.84	-2.0 milliseconds (msec) Standard Deviation 6.58
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 10 hr Post dose	5.0 milliseconds (msec) Standard Deviation 8.14	-0.9 milliseconds (msec) Standard Deviation 9.96
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 12 hr Post dose	1.9 milliseconds (msec) Standard Deviation 9.25	3.4 milliseconds (msec) Standard Deviation 8.65
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 16 hr Post dose	1.7 milliseconds (msec) Standard Deviation 7.46	-1.0 milliseconds (msec) Standard Deviation 7.64
Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 24 hr Post dose	-0.7 milliseconds (msec) Standard Deviation 13.32	1.6 milliseconds (msec) Standard Deviation 8.28

PRIMARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: PK/QTc Population included participants who were in both ECG \& PK populations. PK Population included all participants who received at least 1 dose of setmelanotide or moxifloxacin and have at least one quantifiable concentration of setmelanotide or moxifloxacin. ECG Population included all participants in safety population with measurements at baseline as well as on-treatment with at least one post-dose timepoint with a valid value. Participants with available data were reported.

Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant.

QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=21 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 16 hr Post dose	1.4 msec Standard Deviation 7.77	-2.6 msec Standard Deviation 9.30
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 Predose	4.5 msec Standard Deviation 6.49	-2.3 msec Standard Deviation 8.24
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 0.5 hr Post dose	1.0 msec Standard Deviation 8.83	-5.2 msec Standard Deviation 6.97
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 1 hr Post dose	1.6 msec Standard Deviation 9.18	-4.3 msec Standard Deviation 8.20
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 1.5 hr Post dose	0.3 msec Standard Deviation 10.42	-2.9 msec Standard Deviation 8.64
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 2 hr Post dose	2.2 msec Standard Deviation 10.94	-2.0 msec Standard Deviation 8.96
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 2.5 hr Post dose	2.7 msec Standard Deviation 11.61	-2.5 msec Standard Deviation 9.09
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 3 hr Post dose	4.3 msec Standard Deviation 11.34	-2.0 msec Standard Deviation 8.07
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 4 hr Post dose	3.6 msec Standard Deviation 9.88	-2.5 msec Standard Deviation 6.37
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 5 hr Post dose	4.7 msec Standard Deviation 9.41	-0.5 msec Standard Deviation 6.42
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 6 hr Post dose	2.8 msec Standard Deviation 9.64	-2.4 msec Standard Deviation 7.28
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 7 hr Post dose	1.5 msec Standard Deviation 11.14	-2.0 msec Standard Deviation 6.31
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 8 hr Post dose	2.8 msec Standard Deviation 10.02	-2.6 msec Standard Deviation 8.27
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 9 hr Post dose	6.1 msec Standard Deviation 8.72	-1.2 msec Standard Deviation 7.00
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 10 hr Post dose	6.5 msec Standard Deviation 6.64	-2.5 msec Standard Deviation 7.14
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 12 hr Post dose	5.8 msec Standard Deviation 7.96	-0.4 msec Standard Deviation 5.99
Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 24 hr Post dose	1.0 msec Standard Deviation 11.26	-5.6 msec Standard Deviation 9.67

SECONDARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 10 where participants received setmelanotide 3 mg.

The CHFB in HR was analyzed using an analysis of variance model (ANOVA) including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. Placebo corrected values were reported in the inferential statistics.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 Pre dose	2.3 beats per minute (bpm) Standard Deviation 9.65	-0.3 beats per minute (bpm) Standard Deviation 7.31
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 0.5 hr Post dose	-2.0 beats per minute (bpm) Standard Deviation 9.58	0.9 beats per minute (bpm) Standard Deviation 6.39
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1 hr Post dose	-2.7 beats per minute (bpm) Standard Deviation 11.67	1.3 beats per minute (bpm) Standard Deviation 5.79
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1.5 hr Post dose	-0.2 beats per minute (bpm) Standard Deviation 13.13	2.0 beats per minute (bpm) Standard Deviation 5.51
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2 hr Post dose	-2.1 beats per minute (bpm) Standard Deviation 10.94	0.0 beats per minute (bpm) Standard Deviation 6.77
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2.5 hr Post dose	-1.8 beats per minute (bpm) Standard Deviation 9.31	1.7 beats per minute (bpm) Standard Deviation 6.33
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 3 hr Post dose	0.2 beats per minute (bpm) Standard Deviation 10.70	-0.4 beats per minute (bpm) Standard Deviation 8.47
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 4 hr Post dose	-1.2 beats per minute (bpm) Standard Deviation 7.91	-0.6 beats per minute (bpm) Standard Deviation 6.26
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 5 hr Post dose	0.6 beats per minute (bpm) Standard Deviation 7.51	3.1 beats per minute (bpm) Standard Deviation 7.36
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 6 hr Post dose	-1.3 beats per minute (bpm) Standard Deviation 7.66	3.6 beats per minute (bpm) Standard Deviation 5.97
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 7 hr Post dose	-2.9 beats per minute (bpm) Standard Deviation 6.45	0.9 beats per minute (bpm) Standard Deviation 4.74
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 8 hr Post dose	-2.2 beats per minute (bpm) Standard Deviation 5.93	2.4 beats per minute (bpm) Standard Deviation 7.04
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 9 hr Post dose	-1.3 beats per minute (bpm) Standard Deviation 6.34	1.3 beats per minute (bpm) Standard Deviation 6.27
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 10 hr Post dose	-0.8 beats per minute (bpm) Standard Deviation 5.82	0.9 beats per minute (bpm) Standard Deviation 5.33
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 12 hr Post dose	-2.8 beats per minute (bpm) Standard Deviation 7.49	3.3 beats per minute (bpm) Standard Deviation 6.03
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 16 hr Post dose	1.7 beats per minute (bpm) Standard Deviation 6.93	1.9 beats per minute (bpm) Standard Deviation 7.00
Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 24 hr Post dose	2.1 beats per minute (bpm) Standard Deviation 6.04	1.3 beats per minute (bpm) Standard Deviation 5.37

SECONDARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg.

The CHFB in HR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=21 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=25 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 Pre dose	3.4 bpm Standard Deviation 7.41	-0.3 bpm Standard Deviation 4.95
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 0.5 hr Post dose	-1.7 bpm Standard Deviation 9.57	-0.1 bpm Standard Deviation 6.35
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1 hr Post dose	-2.2 bpm Standard Deviation 10.61	0.1 bpm Standard Deviation 5.96
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1.5 hr Post dose	-1.5 bpm Standard Deviation 10.35	1.5 bpm Standard Deviation 5.78
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2 hr Post dose	-3.0 bpm Standard Deviation 7.19	0.5 bpm Standard Deviation 5.14
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2.5 hr Post dose	-0.8 bpm Standard Deviation 7.24	0.4 bpm Standard Deviation 6.49
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 3 hr Post dose	-0.2 bpm Standard Deviation 7.11	2.1 bpm Standard Deviation 5.44
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 4 hr Post dose	1.5 bpm Standard Deviation 6.90	2.0 bpm Standard Deviation 5.18
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 5 hr Post dose	3.5 bpm Standard Deviation 7.84	3.4 bpm Standard Deviation 5.76
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 6 hr Post dose	3.9 bpm Standard Deviation 9.21	0.7 bpm Standard Deviation 5.66
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 7 hr Post dose	1.2 bpm Standard Deviation 6.71	3.3 bpm Standard Deviation 7.68
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 8 hr Post dose	0.8 bpm Standard Deviation 7.13	2.8 bpm Standard Deviation 4.71
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 9 hr Post dose	1.5 bpm Standard Deviation 7.30	1.6 bpm Standard Deviation 6.59
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 10 hr Post dose	2.1 bpm Standard Deviation 7.82	2.8 bpm Standard Deviation 5.16
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 12 hr Post dose	0.6 bpm Standard Deviation 8.00	3.0 bpm Standard Deviation 3.86
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 16 hr Post dose	3.0 bpm Standard Deviation 6.98	3.3 bpm Standard Deviation 4.75
Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 24 hr Post dose	6.2 bpm Standard Deviation 7.41	0.4 bpm Standard Deviation 6.39

SECONDARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg.

The CHFB in QTcF was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 Pre dose	1.9 msec Standard Deviation 7.82	1.5 msec Standard Deviation 7.76
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 0.5 hr Post dose	-3.6 msec Standard Deviation 9.83	-5.3 msec Standard Deviation 8.75
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1 hr Post dose	-2.9 msec Standard Deviation 12.69	-3.7 msec Standard Deviation 9.39
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1.5 hr Post dose	-3.0 msec Standard Deviation 9.53	0.9 msec Standard Deviation 8.56
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2 hr Post dose	-1.0 msec Standard Deviation 11.26	2.0 msec Standard Deviation 8.74
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2.5 hr Post dose	1.2 msec Standard Deviation 11.22	4.9 msec Standard Deviation 8.75
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 3 hr Post dose	2.1 msec Standard Deviation 10.06	4.9 msec Standard Deviation 7.39
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 4 hr Post dose	2.0 msec Standard Deviation 9.76	6.3 msec Standard Deviation 8.63
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 5 hr Post dose	2.4 msec Standard Deviation 9.38	8.1 msec Standard Deviation 8.42
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 6 hr Post dose	-0.4 msec Standard Deviation 9.71	6.0 msec Standard Deviation 6.61
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 7 hr Post dose	1.0 msec Standard Deviation 8.02	5.1 msec Standard Deviation 8.39
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 8 hr Post dose	2.6 msec Standard Deviation 9.11	4.4 msec Standard Deviation 8.18
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 9 hr Post dose	4.1 msec Standard Deviation 7.84	5.0 msec Standard Deviation 10.47
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 10 hr Post dose	5.0 msec Standard Deviation 8.14	6.2 msec Standard Deviation 6.85
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 12 hr Post dose	1.9 msec Standard Deviation 9.25	8.7 msec Standard Deviation 4.84
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 16 hr Post dose	1.7 msec Standard Deviation 7.46	5.9 msec Standard Deviation 8.09
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 24 hr Post dose	-0.7 msec Standard Deviation 13.32	6.6 msec Standard Deviation 8.00

SECONDARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg.

The CHFB in QTcF was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=21 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=25 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 Pre dose	4.5 msec Standard Deviation 6.49	-0.8 msec Standard Deviation 8.30
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 0.5 hr Post dose	1.0 msec Standard Deviation 8.83	-1.8 msec Standard Deviation 5.93
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1 hr Post dose	1.6 msec Standard Deviation 9.18	-1.9 msec Standard Deviation 7.49
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1.5 hr Post dose	0.3 msec Standard Deviation 10.42	3.0 msec Standard Deviation 7.05
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2 hr Post dose	2.2 msec Standard Deviation 10.94	4.2 msec Standard Deviation 7.53
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2.5 hr Post dose	2.7 msec Standard Deviation 11.61	7.6 msec Standard Deviation 8.45
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 3 hr Post dose	4.3 msec Standard Deviation 11.34	8.1 msec Standard Deviation 8.19
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 4 hr Post dose	3.6 msec Standard Deviation 9.88	8.8 msec Standard Deviation 6.37
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 5 hr Post dose	4.7 msec Standard Deviation 9.41	7.5 msec Standard Deviation 8.97
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 6 hr Post dose	2.8 msec Standard Deviation 9.64	8.5 msec Standard Deviation 6.18
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 7 hr Post dose	1.5 msec Standard Deviation 11.14	9.1 msec Standard Deviation 7.29
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 8 hr Post dose	2.8 msec Standard Deviation 10.02	8.0 msec Standard Deviation 5.73
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 9 hr Post dose	6.1 msec Standard Deviation 8.72	7.0 msec Standard Deviation 7.33
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 10 hr Post dose	6.5 msec Standard Deviation 6.64	7.0 msec Standard Deviation 9.93
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 12 hr Post dose	5.8 msec Standard Deviation 7.96	10.8 msec Standard Deviation 9.14
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 16 hr Post dose	1.4 msec Standard Deviation 7.77	6.6 msec Standard Deviation 8.51
Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 24 hr Post dose	1.0 msec Standard Deviation 11.26	4.4 msec Standard Deviation 10.57

SECONDARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg.

The CHFB in PR was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 Pre dose	-2.4 msec Standard Deviation 6.12	3.1 msec Standard Deviation 5.18
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 0.5 hr Post dose	-3.8 msec Standard Deviation 8.93	3.4 msec Standard Deviation 8.29
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1 hr Post dose	-1.0 msec Standard Deviation 6.22	3.5 msec Standard Deviation 7.33
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1.5 hr Post dose	-1.0 msec Standard Deviation 6.24	3.7 msec Standard Deviation 7.04
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2 hr Post dose	-1.0 msec Standard Deviation 6.98	3.3 msec Standard Deviation 7.44
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2.5 hr Post dose	-3.1 msec Standard Deviation 4.92	1.5 msec Standard Deviation 6.53
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 3 hr Post dose	-3.9 msec Standard Deviation 7.81	2.6 msec Standard Deviation 6.76
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 4 hr Post dose	-1.2 msec Standard Deviation 5.78	1.6 msec Standard Deviation 8.41
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 5 hr Post dose	-1.0 msec Standard Deviation 6.61	0.5 msec Standard Deviation 5.46
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 6 hr Post dose	-1.7 msec Standard Deviation 5.87	-0.2 msec Standard Deviation 6.62
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 7 hr Post dose	-2.5 msec Standard Deviation 4.88	0.3 msec Standard Deviation 5.06
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 8 hr Post dose	-1.9 msec Standard Deviation 7.06	0.3 msec Standard Deviation 7.37
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 9 hr Post dose	-2.3 msec Standard Deviation 6.03	0.5 msec Standard Deviation 4.49
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 10 hr Post dose	-1.2 msec Standard Deviation 7.06	-0.8 msec Standard Deviation 6.30
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 12 hr Post dose	-3.9 msec Standard Deviation 7.83	-2.1 msec Standard Deviation 6.05
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 16 hr Post dose	-3.0 msec Standard Deviation 7.02	-0.0 msec Standard Deviation 7.24
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 24 hr Post dose	-6.6 msec Standard Deviation 8.39	1.2 msec Standard Deviation 5.65

SECONDARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg.

The CHFB in PR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=21 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=25 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 Pre dose	-3.5 msec Standard Deviation 7.11	3.4 msec Standard Deviation 11.46
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 0.5 hr Post dose	-4.5 msec Standard Deviation 11.01	3.9 msec Standard Deviation 9.88
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1 hr Post dose	0.4 msec Standard Deviation 7.72	5.8 msec Standard Deviation 10.90
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1.5 hr Post dose	-2.3 msec Standard Deviation 7.45	2.4 msec Standard Deviation 9.42
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2 hr Post dose	0.1 msec Standard Deviation 6.67	2.0 msec Standard Deviation 8.17
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2.5 hr Post dose	-0.9 msec Standard Deviation 7.36	3.2 msec Standard Deviation 7.46
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 3 hr Post dose	-2.2 msec Standard Deviation 7.12	2.0 msec Standard Deviation 8.00
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 4 hr Post dose	-1.3 msec Standard Deviation 6.34	1.3 msec Standard Deviation 9.51
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 5 hr Post dose	-2.6 msec Standard Deviation 6.70	1.2 msec Standard Deviation 9.99
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 6 hr Post dose	-1.7 msec Standard Deviation 7.99	0.7 msec Standard Deviation 8.87
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 7 hr Post dose	-3.7 msec Standard Deviation 5.65	-1.1 msec Standard Deviation 9.29
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 8 hr Post dose	-3.1 msec Standard Deviation 5.97	0.8 msec Standard Deviation 8.52
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 9 hr Post dose	-3.4 msec Standard Deviation 5.08	0.4 msec Standard Deviation 7.66
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 10 hr Post dose	-1.4 msec Standard Deviation 6.36	1.1 msec Standard Deviation 7.80
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 12 hr Post dose	-1.9 msec Standard Deviation 5.77	0.8 msec Standard Deviation 7.27
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 16 hr Post dose	-4.9 msec Standard Deviation 6.64	0.9 msec Standard Deviation 8.78
Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 24 hr Post dose	-8.4 msec Standard Deviation 9.21	2.5 msec Standard Deviation 7.28

SECONDARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg.

The CHFB in QRS was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 Pre dose	-0.2 msec Standard Deviation 4.90	0.9 msec Standard Deviation 3.42
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 0.5 hr Post dose	0.0 msec Standard Deviation 3.85	0.6 msec Standard Deviation 6.31
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1 hr Post dose	0.5 msec Standard Deviation 5.21	0.8 msec Standard Deviation 3.38
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 1.5 hr Post dose	-0.6 msec Standard Deviation 3.69	-0.2 msec Standard Deviation 3.06
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2 hr Post dose	0.2 msec Standard Deviation 4.04	0.1 msec Standard Deviation 3.37
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 2.5 hr Post dose	0.2 msec Standard Deviation 4.41	0.5 msec Standard Deviation 4.70
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 3 hr Post dose	0.7 msec Standard Deviation 4.31	0.4 msec Standard Deviation 3.60
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 4 hr Post dose	0.6 msec Standard Deviation 3.95	-0.7 msec Standard Deviation 3.94
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 5 hr Post dose	0.5 msec Standard Deviation 3.82	1.0 msec Standard Deviation 3.88
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 6 hr Post dose	0.4 msec Standard Deviation 4.71	-0.4 msec Standard Deviation 3.92
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 7 hr Post dose	0.9 msec Standard Deviation 5.30	0.1 msec Standard Deviation 3.66
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 8 hr Post dose	0.2 msec Standard Deviation 4.23	1.1 msec Standard Deviation 3.85
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 9 hr Post dose	-0.2 msec Standard Deviation 4.19	-0.1 msec Standard Deviation 2.93
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 10 hr Post dose	1.6 msec Standard Deviation 4.23	0.2 msec Standard Deviation 3.95
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 12 hr Post dose	0.8 msec Standard Deviation 5.08	1.9 msec Standard Deviation 4.10
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 16 hr Post dose	1.0 msec Standard Deviation 4.77	1.5 msec Standard Deviation 3.97
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 24 hr Post dose	-0.3 msec Standard Deviation 5.38	1.6 msec Standard Deviation 4.53

SECONDARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg.

The CHFB in QRS was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=21 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=25 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 Pre dose	1.0 msec Standard Deviation 4.11	-0.8 msec Standard Deviation 3.90
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 0.5 hr Post dose	0.5 msec Standard Deviation 3.57	0.2 msec Standard Deviation 3.90
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1 hr Post dose	0.9 msec Standard Deviation 3.20	-1.0 msec Standard Deviation 6.86
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 1.5 hr Post dose	-0.8 msec Standard Deviation 3.06	-0.4 msec Standard Deviation 3.65
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2 hr Post dose	-0.2 msec Standard Deviation 3.97	0.3 msec Standard Deviation 3.41
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 2.5 hr Post dose	1.1 msec Standard Deviation 2.95	-0.2 msec Standard Deviation 4.20
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 3 hr Post dose	0.5 msec Standard Deviation 2.91	1.0 msec Standard Deviation 3.69
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 4 hr Post dose	0.7 msec Standard Deviation 4.35	0.5 msec Standard Deviation 2.93
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 5 hr Post dose	-0.2 msec Standard Deviation 4.31	-1.4 msec Standard Deviation 5.54
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 6 hr Post dose	-0.2 msec Standard Deviation 4.63	0.3 msec Standard Deviation 2.99
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 7 hr Post dose	1.5 msec Standard Deviation 4.92	0.7 msec Standard Deviation 4.10
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 8 hr Post dose	-0.2 msec Standard Deviation 4.03	0.7 msec Standard Deviation 2.77
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 9 hr Post dose	0.2 msec Standard Deviation 4.13	-0.4 msec Standard Deviation 3.15
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 10 hr Post dose	1.2 msec Standard Deviation 3.19	-1.2 msec Standard Deviation 2.73
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 12 hr Post dose	1.4 msec Standard Deviation 5.13	-0.2 msec Standard Deviation 4.74
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 16 hr Post dose	1.1 msec Standard Deviation 2.90	-0.7 msec Standard Deviation 4.75
Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 24 hr Post dose	1.3 msec Standard Deviation 4.68	0.5 msec Standard Deviation 3.69

SECONDARY outcome

Timeframe: Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

Population: ECG population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively.

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included:

HR (<40 beats/min, HR>120 beats/min and Relative CHFB >25%) Relative CHFB = 100*(Value-Baseline)/Baseline

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=21 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide HR<40 beats/min	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide HR>120 beats/min	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide Relative CHFB in HR>25%	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

Population: ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively.

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included:

PR (>220 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=21 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Number of Participants With at Least One Treatment-Emergent Abnormal Value in PR Intervals After Administration of SC Setmelanotide PR>220 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in PR Intervals After Administration of SC Setmelanotide Relative CHFB in PR>25%	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

Population: ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively.

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included:

QRS ( >120 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=21 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QRS Intervals After Administration of SC Setmelanotide QRS>120 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QRS Intervals After Administration of SC Setmelanotide Relative CHFB in QRS>25%	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

Population: ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively.

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included:

QTcF (450<QTc<=480 msec, 480<QTc<=500 msec, QTc>500 msec, 30<CHFB in QTc<=60 msec, CHFB in >60 msec)

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=21 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide 450<QTc<=480 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide 480<QTc<=500 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide QTc>500 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide 30<CHFB in QTc<=60 msec	0 Participants	0 Participants
Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide CHFB in QTc>60 msec	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

Population: ECG population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively.

A treatment-emergent abnormality/finding will be defined as any abnormality/finding not already reported on any of the ECGs collected before the administration.

Abnormal findings included : QTcF Increase From Baseline, > 30 msec And < 60 msec

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo n=23 Participants Participants received once daily placebo from Days 8 to 10, via SC injection.
Number of Participants With at Least One Treatment-Emergent Abnormal Finding in T-wave Morphology and U-wave Presence After Administration of SC Setmelanotide	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: PK/QTc Population was analyzed. Participants with available data were reported.

Continuous 12-lead digital ECG recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=23 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo Participants received once daily placebo from Days 8 to 10, via SC injection.
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 7 hr Post dose	5.1 msec Standard Deviation 8.39	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 8 hr Post dose	4.4 msec Standard Deviation 8.18	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 9 hr Post dose	5.0 msec Standard Deviation 10.47	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 10 hr Post dose	6.2 msec Standard Deviation 6.85	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 12 hr Post dose	8.7 msec Standard Deviation 4.84	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 16 hr Post dose	5.9 msec Standard Deviation 8.09	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 24 hr Post dose	6.6 msec Standard Deviation 8.00	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 Pre dose	1.5 msec Standard Deviation 7.76	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 0.5 hr Post dose	-5.3 msec Standard Deviation 8.75	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 1 hr Post dose	-3.7 msec Standard Deviation 9.39	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 1.5 hr Post dose	0.9 msec Standard Deviation 8.56	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 2 hr Post dose	2.0 msec Standard Deviation 8.74	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 2.5 hr Post dose	4.9 msec Standard Deviation 8.75	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 3 hr Post dose	4.9 msec Standard Deviation 7.39	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 4 hr Post dose	6.3 msec Standard Deviation 8.63	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 5 hr Post dose	8.1 msec Standard Deviation 8.42	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 10 6 hr Post dose	6.0 msec Standard Deviation 6.61	—

SECONDARY outcome

Timeframe: Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Population: PK/QTc Population was analyzed. Participants with available data were reported.

Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint.

Outcome measures

Measure	Group 1: Setmelanotide 3 mg n=25 Participants Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 3: Placebo Participants received once daily placebo from Days 8 to 10, via SC injection.
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 Pre dose	-0.8 msec Standard Deviation 8.30	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 0.5 hr Post dose	-1.8 msec Standard Deviation 5.93	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 1 hr Post dose	-1.9 msec Standard Deviation 7.49	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 1.5 hr Post dose	3.0 msec Standard Deviation 7.05	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 2 hr Post dose	4.2 msec Standard Deviation 7.53	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 2.5 hr Post dose	7.6 msec Standard Deviation 8.45	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 3 hr Post dose	8.1 msec Standard Deviation 8.19	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 4 hr Post dose	8.8 msec Standard Deviation 6.37	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 5 hr Post dose	7.5 msec Standard Deviation 8.97	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 6 hr Post dose	8.5 msec Standard Deviation 6.18	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 7 hr Post dose	9.1 msec Standard Deviation 7.29	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 8 hr Post dose	8.0 msec Standard Deviation 5.73	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 9 hr Post dose	7.0 msec Standard Deviation 7.33	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 10 hr Post dose	7.0 msec Standard Deviation 9.93	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 12 hr Post dose	10.8 msec Standard Deviation 9.14	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 16 hr Post dose	6.6 msec Standard Deviation 8.51	—
Moxifloxacin Concentration-related CHFB in QTcF at Day 16 24 hr Post dose	4.4 msec Standard Deviation 10.57	—

Adverse Events

Group 1: Setmelanotide 2 mg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Group 1: Setmelanotide 3 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Group 1: Setmelanotide 5 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 1: Setmelanotide 7 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group 2: Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Group 2: Moxifloxacin 400mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 3: Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 3: Moxifloxacin 400mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Setmelanotide 2 mg n=28 participants at risk Participants received once daily setmelanotide 2 mg from Days 1 to 7, via SC injection.	Group 1: Setmelanotide 3 mg n=24 participants at risk Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 1: Setmelanotide 5 mg n=23 participants at risk Participants received once daily setmelanotide 5 mg from Days 11 to 13, via SC injection.	Group 1: Setmelanotide 7 mg n=21 participants at risk Participants received once daily setmelanotide 7 mg from Days 14 to 16, via SC injection.	Group 2: Placebo n=24 participants at risk Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 16.	Group 2: Moxifloxacin 400mg n=23 participants at risk Participants received a single oral dose of 400 mg moxifloxacin on Day 10.	Group 3: Placebo n=25 participants at risk Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 10.	Group 3: Moxifloxacin 400mg n=25 participants at risk Participants received a single oral dose of 400 mg moxifloxacin on Day 16.
Gastrointestinal disorders Pancreatitis acute	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis acute	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.

Other adverse events

Measure	Group 1: Setmelanotide 2 mg n=28 participants at risk Participants received once daily setmelanotide 2 mg from Days 1 to 7, via SC injection.	Group 1: Setmelanotide 3 mg n=24 participants at risk Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection.	Group 1: Setmelanotide 5 mg n=23 participants at risk Participants received once daily setmelanotide 5 mg from Days 11 to 13, via SC injection.	Group 1: Setmelanotide 7 mg n=21 participants at risk Participants received once daily setmelanotide 7 mg from Days 14 to 16, via SC injection.	Group 2: Placebo n=24 participants at risk Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 16.	Group 2: Moxifloxacin 400mg n=23 participants at risk Participants received a single oral dose of 400 mg moxifloxacin on Day 10.	Group 3: Placebo n=25 participants at risk Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 10.	Group 3: Moxifloxacin 400mg n=25 participants at risk Participants received a single oral dose of 400 mg moxifloxacin on Day 16.
General disorders Injection site pain	39.3% 11/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	29.2% 7/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	26.1% 6/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	33.3% 7/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	33.3% 8/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	52.2% 12/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	44.0% 11/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site erythema	25.0% 7/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	41.7% 10/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	30.4% 7/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	9.5% 2/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	26.1% 6/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	24.0% 6/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site pruritus	10.7% 3/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	16.7% 4/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	13.0% 3/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	12.5% 3/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	16.0% 4/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site swelling	14.3% 4/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	13.0% 3/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	19.0% 4/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	17.4% 4/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	36.0% 9/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Fatigue	10.7% 3/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.7% 2/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Asthenia	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Chills	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site induration	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Medical device site dermatitis	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.0% 2/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site bruising	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	12.0% 3/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Injection site discolouration	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
General disorders Vessel puncture site pain	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	46.4% 13/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	17.4% 4/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	9.5% 2/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.0% 2/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	28.6% 8/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	7.1% 2/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	7.1% 2/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.0% 2/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Aphthous ulcer	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Change of bowel habit	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Chapped lips	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival discolouration	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Hyperaesthesia teeth	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Lip discolouration	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Lip dry	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Pigmentation lip	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Tongue pigmentation	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	17.9% 5/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.3% 2/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.3% 2/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ephelides	21.4% 6/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	21.4% 6/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.7% 2/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Nervous system disorders Headache	14.3% 4/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	8.3% 2/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Nervous system disorders Allodynia	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Nervous system disorders Somnolence	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Erection increased	14.3% 4/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dry throat	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.3% 1/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.0% 1/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Investigations SARS-CoV-2 test positive	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.2% 1/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Psychiatric disorders Abnormal dreams	3.6% 1/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.
Psychiatric disorders Disturbance in sexual arousal	0.00% 0/28 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	4.8% 1/21 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/24 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/23 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.	0.00% 0/25 • From first dose up to Day 23 The Safety population included all participants who received at least one dose of study drug.

Additional Information

Rhythm Clinical Trials

Rhythm Pharmaceuticals, Inc.

Phone: 857-264-4280

Email: clinicaltrials@rhythmtx.com

Results disclosure agreements

• Principal investigator is a sponsor employee All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
• Publication restrictions are in place

Restriction type: OTHER