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SAR441255

Phase 1

Overweight | Small molecule | Metabolic |Sanofi|Last Updated: Sep 22, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

SAR441255 · 1 trial · 2 indications

Phase 1 1
NCT04521738First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight SubjectsOverweight
COMPLETED48 Analytics
PHASE1COMPLETED
First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects
OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events
Screening to Day 28

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR441255EXPERIMENTALSingle dose, subcutaneous, escalating dose
PlaceboPLACEBO_COMPARATORSingle dose, subcutaneous, matched volume

Interventions

NameTypeDescription
SAR441255DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
placeboDRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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-den...

Countries:United States
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Frequently asked questions about SAR441255

What is SAR441255 used for?

SAR441255 is an investigational small molecule being developed for the treatment of overweight. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does SAR441255 target?

The molecular target of SAR441255 has not been disclosed. It is a small molecule being studied for its effects on overweight, but its specific mechanism of action is not publicly available.

Who makes SAR441255?

SAR441255 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials.

What phase is SAR441255 in?

SAR441255 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not been approved for any use.

What clinical trials is SAR441255 in?

SAR441255 has been studied in one completed Phase 1 trial, NCT04521738, which assessed the safety and tolerability of a single subcutaneous dose in lean to overweight subjects. The trial enrolled 48 participants in the United States.

Is SAR441255 the same as any other drug?

No alternative names for SAR441255 have been reported. It is identified solely by its code name SAR441255 in clinical trial records.