A Clinical Study to Investigate the Effect of SAR425899 o... | NCT03376802

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

NCT03376802

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 25, 2022Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

SAR425899
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1191-5658	Other Identifier	UTN

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2018Actual

Primary Completion Date

Dec 27, 2018Actual

Completion Date

Dec 27, 2018Actual

First Submitted Date

Dec 12, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAR425899	Experimental	Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days	Drug: SAR425899
Placebo	Placebo Comparator	Repeated once daily SC doses of placebo administered over 19 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAR425899	Drug	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	SAR425899

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep energy expenditure	Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19

Secondary Outcomes

Measure	Description	Time Frame
Total daily energy expenditure	Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo	Baseline to Day 19
Resting energy expenditure	Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 8400001		Orlando	Florida	32804	United States
Investigational Site Number 8400002

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases