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

ID: NCT03376802
Status: Recruiting
Phase: Phase 1
Start Date: February 01, 2018
First Submitted: December 12, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: United States
Conditions: Type 2 Diabetes Mellitus
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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.
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus

Drug: SAR425899
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateDecember 12, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateFebruary 01, 2018
Anticipated Completion DateAugust 24, 2018
Actual Primary Completion DateAugust 24, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Sleep energy expenditure [Time Frame: Baseline to Day 19]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Total daily energy expenditure [Time Frame: Baseline to Day 19]

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

  • Resting energy expenditure [Time Frame: Baseline to Day 19]

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

  • Basal energy expenditure [Time Frame: Baseline to Day 19]

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

  • Respiratory quotient (RQ) [Time Frame: Baseline to Day 19]

    Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo

  • 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

  • Diet Induced Thermogenesis (DIT) [Time Frame: Baseline to Day 19]

    Change of DIT from baseline to Day 19 with SAR425899 or placebo

  • Fasting plasma glucose (FPG) [Time Frame: 20 days]

    Change of FPG over time with SAR425899 or placebo

  • HbA1c [Time Frame: Baseline to Day 20]

    Change of HbA1c from baseline to Day 20 with SAR425899 or placebo

  • 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

  • Ketone bodies [Time Frame: 20 days]

    Change of ketone bodies over time with SAR425899 or placebo

  • Adverse events [Time Frame: Up to 27 days]

    Number of adverse events in patients under treatment with SAR425899 or placebo

  • Pharmacokinetics [Time Frame: Day 16]

    Assessment of SAR425899: time to reach Cmax (tmax)

  • Pharmacokinetics [Time Frame: Day 16]

    Assessment of SAR425899: maximum plasma concentration (Cmax)

  • Pharmacokinetics [Time Frame: Day 16]

    Assessment of SAR425899: area under the concentration versus time curve (AUC)

  • Pharmacokinetics [Time Frame: Day 16]

    Assessment of SAR425899: terminal elimination half-life (t1/2)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Official TitleA 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

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.

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
30
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Basic Science
Conditions
Type 2 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: SAR425899

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Other Names
Drug: Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Other Names
Study Groups/Cohorts
SAR425899
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days

Placebo
Repeated once daily SC doses of placebo administered over 19 days

Study Arms
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

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

Arm Intervention/Treatment
Placebo Comparator Placebo
Repeated once daily SC doses of placebo administered over 19 days
Drug : Placebo
Experimental SAR425899
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days
Drug : SAR425899

Recruitment Information

Recruitment Status:Recruiting
Enrollment30
Completion DateAugust 24, 2018
Eligibility Criteria: Inclusion criteria :
- Overweight to obese male and female subjects.
- Body mass index 28 - 35 kg/m2.
- 18 to 45 years of age
- Fasting plasma glucose ≤125 mg/dL.
- Glycated hemoglobin (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.
GenderAll
Age18 Years to 45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03376802
Other Study ID Numbers
PDY15012
U1111-1191-5658
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi