Back to results

First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

Primary Purpose

Overweight, Healthy Subjects

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SAR441255

placebo

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria :

Male and female subjects, between 18 and 55 years of age, inclusive
Body Mass Index ≥20 and ≤30 kg/m2
Body weight between 65 and 90 kg, inclusive
No concomitant medication
Fasting Plasma Glucose <126 mg/dL
Hemoglobin A1c <6.5%
Triglycerides <300 mg/dL
Low-density lipoprotein (LDL) Cholesterol <200 mg/dL
Permanent sterile or postmenopausal, if female

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness.
Any medication (including over the counter products and any other herbal/alternative remedies such as St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR441255

Placebo

Arm Description

Single dose, subcutaneous, escalating dose

Single dose, subcutaneous, matched volume

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Assessment of pharmacokinetic (PK) parameter: Cmax

Maximum plasma concentration

Assessment of PK parameter: AUC

Area under the plasma concentration versus time curve (AUC)

Assessment of PK parameter: tmax

Time to reach Cmax

Assessment of pharmacodynamics (PD): glucose profile

Change from baseline in glucose profile

Assessment of PD: insulin profile

Change from baseline in insulin profile

Assessment of PD: C-peptide profile

Change from baseline in C-peptide profile

Full Information

NCT ID

NCT04521738

First Posted

August 19, 2020

Last Updated

April 22, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04521738

Brief Title

First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of SAR441255 in Lean to Overweight Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

September 26, 2019 (Actual)

Study Completion Date

September 26, 2019 (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

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)

Detailed Description

Study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Healthy Subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR441255

Arm Type

Experimental

Arm Description

Single dose, subcutaneous, escalating dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single dose, subcutaneous, matched volume

Intervention Type

Drug

Intervention Name(s)

SAR441255

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

Number of participants with adverse events

Time Frame

Screening to Day 28

Secondary Outcome Measure Information:

Title

Assessment of pharmacokinetic (PK) parameter: Cmax

Description

Maximum plasma concentration

Time Frame

Baseline to 96 hrs

Title

Assessment of PK parameter: AUC

Description

Area under the plasma concentration versus time curve (AUC)

Time Frame

Baseline to 96 hrs

Title

Assessment of PK parameter: tmax

Description

Time to reach Cmax

Time Frame

Baseline to 96 hrs

Title

Assessment of pharmacodynamics (PD): glucose profile

Description

Change from baseline in glucose profile

Time Frame

Baseline to 24 hrs

Title

Assessment of PD: insulin profile

Description

Change from baseline in insulin profile

Time Frame

Baseline to 24 hrs

Title

Assessment of PD: C-peptide profile

Description

Change from baseline in C-peptide profile

Time Frame

Baseline to 24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Male and female subjects, between 18 and 55 years of age, inclusive Body Mass Index ≥20 and ≤30 kg/m2 Body weight between 65 and 90 kg, inclusive No concomitant medication Fasting Plasma Glucose <126 mg/dL Hemoglobin A1c <6.5% Triglycerides <300 mg/dL Low-density lipoprotein (LDL) Cholesterol <200 mg/dL Permanent sterile or postmenopausal, if female Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness. Any medication (including over the counter products and any other herbal/alternative remedies such as St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. 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

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

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

Citations:

PubMed Identifier

34932984

Citation

Bossart M, Wagner M, Elvert R, Evers A, Hubschle T, Kloeckener T, Lorenz K, Moessinger C, Eriksson O, Velikyan I, Pierrou S, Johansson L, Dietert G, Dietz-Baum Y, Kissner T, Nowotny I, Einig C, Jan C, Rharbaoui F, Gassenhuber J, Prochnow HP, Agueusop I, Porksen N, Smith WB, Nitsche A, Konkar A. Effects on weight loss and glycemic control with SAR441255, a potent unimolecular peptide GLP-1/GIP/GCG receptor triagonist. Cell Metab. 2022 Jan 4;34(1):59-74.e10. doi: 10.1016/j.cmet.2021.12.005. Epub 2021 Dec 20.

Results Reference

derived

Learn more about this trial

First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

We'll reach out to this number within 24 hrs