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A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects

NCT03376802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-25

No results posted yet for this 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

Interventions

DRUG

SAR425899

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2018-12-27
Completion
2018-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376802 on ClinicalTrials.gov