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NCT04521738 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects
A Phase 1 study of Overweight and Healthy Subjects, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04521738: Completed Phase 1 study of Overweight and Healthy Subjects, sponsored by Sanofi.
NCT04521738 is a Phase 1 study of Overweight and Healthy Subjects that has completed, run by Sanofi. The registered enrollment target is 48 participants, below the 1,323-participant average among 197 other Overweight trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04521738, a Phase 1 study of Overweight and Healthy Subjects, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)
Conditions Studied
Interventions
- DRUG placebo
- DRUG SAR441255
Study Locations (1)
Tennessee
- Investigational site number 8400001 - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 1 |
What the finished NCT04521738 record still lists
NCT04521738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,323-participant average among 197 other Overweight trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Overweight appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT04521738 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04521738 about?
NCT04521738 is a clinical study titled "First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects". Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters ...
What is the current status of trial NCT04521738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-04-25. Estimated completion is 2019-09-26.
What conditions does trial NCT04521738 study?
This clinical trial studies the following conditions: Overweight, Healthy Subjects.
What interventions are being tested in trial NCT04521738?
The interventions under investigation include: placebo (DRUG), SAR441255 (DRUG).
Who is sponsoring clinical trial NCT04521738?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04521738 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overweight
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04521738's enrollment target sits among peer trials
48 152nd of 197 higher than 46 of 197 other Overweight trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overweight 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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