DelfaGLP-1 Atlas

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CompletedPhase 1

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

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

Lead sponsor

Sanofi

Asset

SAR441255

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

—

Enrollment

48

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 20-30•HbA1c ≤6.5%

Primary endpoint

•Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04521738
Org study IDTDU15478
Secondary IDU1111-1210-0180UTN

Timeline

Milestones

Study start2019-04-25actual
Primary completion2019-09-26actual
Study completion2019-09-26actual
Study first posted2020-08-20actual
Last update posted2025-09-22actual

Assets

Investigational agents

SAR441255

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Glycemic / diabetes
3

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Assessment of pharmacodynamics (PD): glucose profile

Time frame:Baseline to 24 hrs

descriptive

Secondary/protocol endpoint

Assessment of PD: insulin profile

Time frame:Baseline to 24 hrs

descriptive

Secondary/protocol endpoint

Assessment of PD: C-peptide profile

Time frame:Baseline to 24 hrs

descriptive

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Number of participants with adverse events

Time frame:Screening to Day 28

event count, event

Secondary/protocol endpoint

Assessment of pharmacokinetic (PK) parameter: Cmax

Time frame:Baseline to 96 hrs

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameter: AUC

Time frame:Baseline to 96 hrs

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameter: tmax

Time frame:Baseline to 96 hrs

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.