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NCT03414736 · ClinicalTrials.gov registry record · Phase 1
A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03414736: Completed Phase 1 study, sponsored by Sanofi.
NCT03414736 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414736, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Primary Objectives: * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs). * Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs. Secondary Objectives: Main study and 6-month study extension period: To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy: * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c). * Safety and tolerability.
Primary Outcome
Relative frequency of GI AEs
Interventions
- DRUG SAR425899
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-01-19 |
| Est. Completion | 2018-10-05 |
| Phase | Phase 1 |
What the finished NCT03414736 record still lists
NCT03414736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which SAR425899 is the first listed.
NCT03414736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03414736 about?
NCT03414736 is a clinical study titled "A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period". Primary Objectives: * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and s...
What is the current status of trial NCT03414736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-01-19. Estimated completion is 2018-10-05.
What interventions are being tested in trial NCT03414736?
The interventions under investigation include: SAR425899 (DRUG).
Who is sponsoring clinical trial NCT03414736?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03414736's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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