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

• ClinicalTrials.gov Identifier: NCT03376802
• Recruitment Status: Completed
• First Posted: December 19, 2017
• Last Update Posted: April 25, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: SAR425899; Drug: Placebo	Phase 1

Detailed Description:

Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: December 27, 2018
• Actual Study Completion Date: December 27, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: SAR425899; Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days	Drug: SAR425899; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Placebo Comparator: Placebo; Repeated once daily SC doses of placebo administered over 19 days	Drug: Placebo; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Outcome Measures

Primary Outcome Measures :

1. Sleep energy expenditure [ Time Frame: Baseline to Day 19 ]
   Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo

Secondary Outcome Measures :

1. Total daily energy expenditure [ Time Frame: Baseline to Day 19 ]
   Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
2. Resting energy expenditure [ Time Frame: Baseline to Day 19 ]
   Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo
3. Basal energy expenditure [ Time Frame: Baseline to Day 19 ]
   Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
4. Respiratory quotient (RQ) [ Time Frame: Baseline to Day 19 ]
   Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
5. Fat mass and fat-free mass [ Time Frame: Baseline to Day 20 ]
   Change of fat mass and fat-free mass by dual energy X-ray absorptiometry (DEXA) scan from baseline to Day 20 with SAR425899 or placebo
6. Diet Induced Thermogenesis (DIT) [ Time Frame: Baseline to Day 19 ]
   Change of DIT from baseline to Day 19 with SAR425899 or placebo
7. Fasting plasma glucose [ Time Frame: 20 days ]
   Change of FPG over time with SAR425899 or placebo
8. HbA1c [ Time Frame: Baseline to Day 20 ]
   Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
9. Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol) [ Time Frame: 20 days ]
   Change of lipid biomarkers over time with SAR425899 or placebo
10. Ketone bodies [ Time Frame: 20 days ]
    Change of ketone bodies over time with SAR425899 or placebo
11. Adverse events [ Time Frame: Up to 27 days ]
    Number of adverse events in patients under treatment with SAR425899 or placebo
12. Pharmacokinetics [ Time Frame: Day 16 ]
    Assessment of SAR425899: time to reach Cmax (tmax)
13. Pharmacokinetics [ Time Frame: Day 16 ]
    Assessment of SAR425899: maximum plasma concentration (Cmax)
14. Pharmacokinetics [ Time Frame: Day 16 ]
    Assessment of SAR425899: area under the concentration versus time curve (AUC)
15. Pharmacokinetics [ Time Frame: Day 16 ]
    Assessment of SAR425899: terminal elimination half-life (t1/2)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

• Overweight to obese male and female subjects.
• Body mass index 28 - 40 kg/m2.
• 18 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.

Exclusion criteria:

• 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.

Contacts and Locations

Locations

United States, Florida

Investigational Site Number 8400001

Orlando, Florida, United States, 32804

United States, Louisiana

Investigational Site Number 8400002

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03376802
• Other Study ID Numbers: PDY15012; U1111-1191-5658 ( Other Identifier: UTN )
• First Posted: December 19, 2017
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases