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

NCT03376802 | Completed Phase 1 FDA Drug

• 2 other identifiers: PDY15012U1111-1191-5658
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Sleep energy expenditure

  Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo

  Baseline to Day 19

Secondary Outcomes (15)

• Total daily energy expenditure

  Baseline to Day 19

• Resting energy expenditure

  Baseline to Day 19

• Basal energy expenditure

  Baseline to Day 19

• Respiratory quotient (RQ)

  Baseline to Day 19

• Fat mass and fat-free mass

  Baseline to Day 20

Study Arms (2)

SAR425899

EXPERIMENTAL

Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days

Drug: SAR425899

Placebo

PLACEBO COMPARATOR

Repeated once daily SC doses of placebo administered over 19 days

Drug: Placebo

Interventions

SAR425899 DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

SAR425899

Placebo DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight to obese male and female subjects.
• Body mass index 28 - 40 kg/m2.
• to 50 years of age
• Fasting plasma glucose ≤125 mg/dL.
• Glycated hemoglobine (HbA1c) ≤6.5%.
• Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia).
• No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker).
• Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.

You may not qualify if:

• Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
• Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.
• Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number 8400001

Orlando, Florida, 32804, United States

Location

Investigational Site Number 8400002

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SAR425899

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 19, 2017
• Study Start: April 18, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)