A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Public ClinicalTrials.gov record NCT03376802. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03376802
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 17, 2018
- Primary completion
- Dec 26, 2018
- Completion
- Dec 26, 2018
- Last update posted
- Apr 24, 2022
2018
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400001 | Orlando | Florida | 32804 | — |
| Investigational Site Number 8400002 | Baton Rouge | Louisiana | 70808 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03376802, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03376802 live on ClinicalTrials.gov.