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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376802
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

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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

Resource links provided by the National Library of Medicine


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





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)



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376802


Locations
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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
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03376802    
Other Study ID Numbers: PDY15012
U1111-1191-5658 ( Other Identifier: UTN )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
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://www.clinicalstudydatarequest.com/

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