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New drug SAR441255 tested in humans for first time

NCT ID NCT04521738

Knowledge-focused Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested a single dose of a new drug called SAR441255 in 48 healthy, lean to overweight adults. The main goal was to check safety and how the body processes the drug. Researchers also looked at effects on blood sugar and insulin levels. This is a first step to see if the drug might help with weight or diabetes in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR441255
What this could lead to
If successful, this could point toward a new treatment for diabetes or weight management.
What could go wrong
This is a very early Phase 1 trial with only 48 participants, so it's mainly checking safety. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Started

Apr 2019

Finished

Sep 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects Overweight

Contacts and locations

Locations

  • Investigational site number 8400001

    Knoxville, Tennessee, 37920, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.