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NCT03376802 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT03376802: Completed Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Sanofi.
NCT03376802 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 24 participants, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03376802, a Phase 1 study of Type 2 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899. Secondary Objectives: * To assess the change in resting, basal and total daily energy expenditure. * To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation. * To assess the change in body composition and core temperature. * To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c). * To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses. * To assess the safety and tolerability.
Primary Outcome
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR425899
Study Locations (2)
Florida
- Investigational Site Number 8400001 - Orlando
Louisiana
- Investigational Site Number 8400002 - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2018-12-27 |
| Phase | Phase 1 |
What the finished NCT03376802 record still lists
NCT03376802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03376802 reports a single indexed study location in Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT03376802 about?
NCT03376802 is a clinical study titled "A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects". Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899. Secondary Objectives: * To assess the change in resting, basal and total daily energy expenditure. * To assess the change in respiratory quotien...
What is the current status of trial NCT03376802?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-04-18. Estimated completion is 2018-12-27.
What conditions does trial NCT03376802 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT03376802?
The interventions under investigation include: Placebo (DRUG), SAR425899 (DRUG).
Who is sponsoring clinical trial NCT03376802?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03376802 being conducted?
This trial has 2 study locations across Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03376802's enrollment target sits among peer trials
24 101st of 130 higher than 24 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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.
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