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

NCT04521738 | Completed Phase 1 FDA Drug

• 2 other identifiers: TDU15478U1111-1210-0180
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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)

Conditions

Overweight; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Screening to Day 28

Secondary Outcomes (6)

• Assessment of pharmacokinetic (PK) parameter: Cmax

  Baseline to 96 hrs

• Assessment of PK parameter: AUC

  Baseline to 96 hrs

• Assessment of PK parameter: tmax

  Baseline to 96 hrs

• Assessment of pharmacodynamics (PD): glucose profile

  Baseline to 24 hrs

• Assessment of PD: insulin profile

  Baseline to 24 hrs

Study Arms (2)

SAR441255

EXPERIMENTAL

Single dose, subcutaneous, escalating dose

Drug: SAR441255

Placebo

PLACEBO COMPARATOR

Single dose, subcutaneous, matched volume

Drug: placebo

Interventions

SAR441255 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR441255

placebo DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site number 8400001

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• 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.

  PMID: 34932984 DERIVED

Related Links

• TDU15478 Plain Language Results Summary

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 20, 2020
• Study Start: April 25, 2019
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)