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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR425899
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site Number 8400001
  • Investigational Site Number 8400002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR425899

Placebo

Arm Description

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

Repeated once daily SC doses of placebo administered over 19 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total daily energy expenditure
Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
Resting energy expenditure
Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo
Basal energy expenditure
Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
Respiratory quotient (RQ)
Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
Fat mass and fat-free mass
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
Diet Induced Thermogenesis (DIT)
Change of DIT from baseline to Day 19 with SAR425899 or placebo
Fasting plasma glucose
Change of FPG over time with SAR425899 or placebo
HbA1c
Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)
Change of lipid biomarkers over time with SAR425899 or placebo
Ketone bodies
Change of ketone bodies over time with SAR425899 or placebo
Adverse events
Number of adverse events in patients under treatment with SAR425899 or placebo
Pharmacokinetics
Assessment of SAR425899: time to reach Cmax (tmax)
Pharmacokinetics
Assessment of SAR425899: maximum plasma concentration (Cmax)
Pharmacokinetics
Assessment of SAR425899: area under the concentration versus time curve (AUC)
Pharmacokinetics
Assessment of SAR425899: terminal elimination half-life (t1/2)

Full Information

First Posted
December 12, 2017
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03376802
Brief Title
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
December 27, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR425899
Arm Type
Experimental
Arm Description
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Repeated once daily SC doses of placebo administered over 19 days
Intervention Type
Drug
Intervention Name(s)
SAR425899
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Sleep energy expenditure
Description
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Secondary Outcome Measure Information:
Title
Total daily energy expenditure
Description
Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Title
Resting energy expenditure
Description
Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Title
Basal energy expenditure
Description
Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Title
Respiratory quotient (RQ)
Description
Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Title
Fat mass and fat-free mass
Description
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
Time Frame
Baseline to Day 20
Title
Diet Induced Thermogenesis (DIT)
Description
Change of DIT from baseline to Day 19 with SAR425899 or placebo
Time Frame
Baseline to Day 19
Title
Fasting plasma glucose
Description
Change of FPG over time with SAR425899 or placebo
Time Frame
20 days
Title
HbA1c
Description
Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
Time Frame
Baseline to Day 20
Title
Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)
Description
Change of lipid biomarkers over time with SAR425899 or placebo
Time Frame
20 days
Title
Ketone bodies
Description
Change of ketone bodies over time with SAR425899 or placebo
Time Frame
20 days
Title
Adverse events
Description
Number of adverse events in patients under treatment with SAR425899 or placebo
Time Frame
Up to 27 days
Title
Pharmacokinetics
Description
Assessment of SAR425899: time to reach Cmax (tmax)
Time Frame
Day 16
Title
Pharmacokinetics
Description
Assessment of SAR425899: maximum plasma concentration (Cmax)
Time Frame
Day 16
Title
Pharmacokinetics
Description
Assessment of SAR425899: area under the concentration versus time curve (AUC)
Time Frame
Day 16
Title
Pharmacokinetics
Description
Assessment of SAR425899: terminal elimination half-life (t1/2)
Time Frame
Day 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8400001
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site Number 8400002
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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

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