Clinical trial NCT04521738: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Healthy Subjects
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Screening to Day 28
Secondary outcomes:
measure: Assessment of pharmacokinetic (PK) parameter: Cmax
timeFrame: Baseline to 96 hrs
measure: Assessment of PK parameter: AUC
timeFrame: Baseline to 96 hrs
measure: Assessment of PK parameter: tmax
timeFrame: Baseline to 96 hrs
measure: Assessment of pharmacodynamics (PD): glucose profile
timeFrame: Baseline to 24 hrs
measure: Assessment of PD: insulin profile
timeFrame: Baseline to 24 hrs
measure: Assessment of PD: C-peptide profile
timeFrame: Baseline to 24 hrs
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Investigational site number 8400001
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.