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Trial record 1 of 1 for:    PDY15012
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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 : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date April 25, 2022
Actual Study Start Date  ICMJE April 18, 2018
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • 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 [ 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  ICMJE
 (submitted: December 12, 2017)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: SAR425899

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • Drug: Placebo

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

Study Arms  ICMJE
  • Experimental: SAR425899
    Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days
    Intervention: Drug: SAR425899
  • Placebo Comparator: Placebo
    Repeated once daily SC doses of placebo administered over 19 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
30
Actual Study Completion Date  ICMJE December 27, 2018
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03376802
Other Study ID Numbers  ICMJE PDY15012
U1111-1191-5658 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP