Trial Outcomes & Findings for A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016) (NCT NCT00880763)

Last Updated: 2018-10-09

Results Overview

Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was \<1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Week 4

Results posted on

2018-10-09

Participant Flow

Initial treatment period (Part 1) includes up through Week 6; Extension period (Part 2) includes from Week 6 through Week 96.

Participant milestones

Participant milestones
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Initial Treatment Period (Part 1) STARTED	23	22	23	22
Initial Treatment Period (Part 1) COMPLETED	23	22	23	22
Initial Treatment Period (Part 1) NOT COMPLETED	0	0	0	0
Extension Period (Part 2) STARTED	23	22	23	22
Extension Period (Part 2) COMPLETED	23	19	20	19
Extension Period (Part 2) NOT COMPLETED	0	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaniprevir 600 mg + Peg-IFN + Ribavirin Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Extension Period (Part 2) Adverse Event	0	1	1
Extension Period (Part 2) Withdrawal by Subject	2	1	1
Extension Period (Part 2) Physician Decision	1	1	0
Extension Period (Part 2) Lack of Efficacy	0	0	1

Baseline Characteristics

A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=22 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Total n=90 Participants Total of all reporting groups
Age, Continuous	55.0 Years STANDARD_DEVIATION 6.5 • n=5 Participants	54.3 Years STANDARD_DEVIATION 7.6 • n=7 Participants	56.3 Years STANDARD_DEVIATION 7.8 • n=5 Participants	54.7 Years STANDARD_DEVIATION 6.9 • n=4 Participants	55.1 Years STANDARD_DEVIATION 7.1 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	45 Participants n=21 Participants
Region of Enrollment Japan	23 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	22 Participants n=4 Participants	90 Participants n=21 Participants
Genotype Genotype 1a	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Genotype Genotype 1b	22 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	21 Participants n=4 Participants	87 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=20 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=21 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=20 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Percentage of Participants Achieving Rapid Viral Response	86.4 Percentage of participants	95.0 Percentage of participants	76.2 Percentage of participants	20.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=20 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=21 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=20 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	95 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=20 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=21 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=20 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	85 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.

Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=20 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=21 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=20 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Change From Baseline in HCV RNA in log10 at Week 4 Baseline	6.6 IU/mL in Log10 Standard Deviation 0.6 • Interval -6.8 to -6.1	6.6 IU/mL in Log10 Standard Deviation 0.6 • Interval -7.0 to -6.2	6.6 IU/mL in Log10 Standard Deviation 0.8 • Interval -6.7 to -6.0	6.6 IU/mL in Log10 Standard Deviation 0.5 • Interval -5.1 to -4.3
Change From Baseline in HCV RNA in log10 at Week 4 Change from Baseline	-6.5 IU/mL in Log10 Standard Deviation 0.6	-6.6 IU/mL in Log10 Standard Deviation 0.6	-6.3 IU/mL in Log10 Standard Deviation 0.8	-4.7 IU/mL in Log10 Standard Deviation 1.6

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=22 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Number of Participants Who Experienced at Least One Adverse Event	23 Participants	22 Participants	23 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=22 Participants Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=23 Participants Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=22 Participants Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Vaniprevir 200 mg + Peg-IFN + Ribavirin

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Vaniprevir 600 mg + Peg-IFN + Ribavirin

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Vaniprevir 1200 mg + Peg-IFN + Ribavirin

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo + Peg-IFN + Ribavirin

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vaniprevir 200 mg + Peg-IFN + Ribavirin n=23 participants at risk Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 600 mg + Peg-IFN + Ribavirin n=22 participants at risk Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Vaniprevir 1200 mg + Peg-IFN + Ribavirin n=23 participants at risk Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.	Placebo + Peg-IFN + Ribavirin n=22 participants at risk Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Eye disorders Cataract	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Gastrointestinal disorders Inguinal hernia	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Hepatobiliary disorders Hepatic steatosis	4.3% 1/23 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Bacterial infection	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Infective spondylitis	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Metabolism and nutrition disorders Diabetes mellitus	4.3% 1/23 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.
Renal and urinary disorders Renal failure acute	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/22 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/23 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • Non-serious adverse events: up to 6 weeks (Part 1 only); Serious adverse events: up to 96 weeks (Parts 1 and 2 including 24-week follow-up period) All participants as treated population consists of all randomized participants who received at least one dose of study. Participants are included in the treatment group corresponding to the study treatment they actually received.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER