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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 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 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03376802
The ClinicalTrials.gov registry entry for NCT03376802 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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