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Small Molecule

Venglustat for Liver Dysfunction

Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 20
Awards & highlights

Study Summary

This trial studies the effects of hepatic impairment on venglustat exposure in male and female participants aged 18-79. They will receive a single dose and be monitored for 42 days.

Who is the study for?
Adults aged 18-79 with varying degrees of liver dysfunction (mild, moderate, severe) or normal liver function can join this study. They must weigh within certain limits and have a BMI of 18-40 kg/m2. Participants need to use double contraception methods and cannot be pregnant or donating sperm/ova. Those with stable chronic liver disease are eligible if they meet specific lab criteria.Check my eligibility
What is being tested?
The trial is testing the effects of a single dose of Venglustat on adults with different levels of hepatic impairment compared to those with normal liver function. It's an open-label study where participants will stay in the institution until Day 5 post-dosing and attend several follow-up visits over approximately six weeks.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects for Venglustat may include issues related to its impact on liver function since it's being tested specifically for pharmacokinetics in individuals with hepatic impairments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Maximum venglustat plasma concentration observed (Cmax)
Secondary outcome measures
Number of participants with adverse event (AE), treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI)
Time to maximum venglustat plasma concentration (tmax)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Participants with severe hepatic impairmentExperimental Treatment1 Intervention
Venglustat single dose on Day 1
Group II: Participants with normal hepatic functionExperimental Treatment1 Intervention
Venglustat single dose on Day 1
Group III: Participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Venglustat single dose on Day 1
Group IV: Participants with mild hepatic impairmentExperimental Treatment1 Intervention
Venglustat single dose on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venglustat (GZ402671)
2023
Completed Phase 1
~30

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Who is running the clinical trial?

SanofiLead Sponsor
2,171 Previous Clinical Trials
3,517,065 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,368 Total Patients Enrolled
~11 spots leftby Jun 2025
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