Restore

WithdrawnPhase 2

Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease

A 52-week Double-blind, Randomized, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of SAR425899 for the Treatment of Non-alcoholic Steatohepatitis (NASH)

Lead sponsor

Sanofi

Asset

SAR425899

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

MASH / NAFLD / liver fibrosis

Key I/E criterion

•HbA1c ≤6.5%

Primary endpoint

•MASH resolution, no fibrosis worsening

Identifiers

Registered as

NCT IDNCT03437720

Org study IDACT15067

Secondary ID2017-002371-26

Secondary IDU1111-1191-5486UTN

Timeline

Milestones

Study first posted2018-02-19actual

Study start2019-05-23estimated

Primary completion2021-08-25estimated

Study completion2021-08-25estimated

Last update posted2022-04-13actual

Assets

Investigational agents

SAR425899

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Non-diabetic or type 2 diabetes mellitus with confirmed non-alcoholic steatohepatitis.

•Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) >=4 with each of its components >=1.

•Patients without Type 2 diabetes determined by HbA1c (glycated hemoglobin) <6.5% and Fasting Plasma Glucose (FPG) <7.0 mmol/L (<126 mg/dL).

•Stable glycemic control (HbA1c <9.0%) and metabolic disorders managed with diet/exercise and/or stable dose metformin and/or sulphonylureas for at least 3 months prior to screening (type 2 diabetes patients).

•Signed written informed consent form.

Exclusion criteria

•Diagnosis of type 1 diabetes mellitus.

•Previous insulin use or use of insulin within the last 6 months, except for episode(s) of short-term treatment (<15 consecutive days) due to intercurrent illness.

•Body Mass Index (BMI) <25 kg/m2 or >45.0 kg/m2.

•Current participation in organized diet/weight reduction program or clinical trial of weight control (within the last 3 months prior to screening), or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening (significant change in body weight is defined as >=5% self-reported change within 6 months prior to randomization if a pre-existing liver biopsy sample was collected prior to screening period.

•Current treatment with glucose-lowering agent(s) other than metformin or sulphonylureas, weight loss drugs including orlistat, systemic steroids, methotrexate, amiodarone, or Vitamin E.

•Alcoholism (past or present) and/or average alcohol consumption per week >21 units (210

g)for males, >14 units (140

g)for females within the last 5 years.

•Poorly controlled hypertension (resting systolic blood pressure (SBP) >160 mm Hg and/or resting diastolic blood pressure (DBP) >95 mm Hg) at screening.

•Some liver diseases, pancreatic disease, liver transplantation and types of cancer.

•Pregnant or breast-feeding women.

•Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

•Male subjects, whose partners are able to become pregnant, who do not accept to use a condom during sexual intercourse from study inclusion up to 3 months after last dosing; or who are planning to donate sperm from study inclusion up to 3 months after last dosing.

•Patients with coronary, carotid, or peripheral artery revascularization procedures planned during the screening or treatment phases of the protocol.

•Patients with unstable heart conditions.

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

Endpoints (17)

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

MASH / liver

Weight & body composition

Safety / tolerability / PK

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Major adverse cardiac events

Time frame:Baseline to week 52

Expanded / custom MACE composite

event count, event

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in hip circumference

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in waist to hip ratio

Time frame:Baseline to week 52

change from baseline, improvement

MASH / liver

9 endpoints

Primary/protocol endpoint

Resolution of Non-alcoholic steatohepatitis (NASH)

Time frame:Week 52

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Secondary/protocol endpoint

No hepatocyte ballooning, lobular inflammation score 0 or 1, without worsening of fibrosis

Time frame:Week 52

categorical status, improvement

Secondary/protocol endpoint

Change in overall NAFLD activity score (NAS)

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in NAS individual components

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in NAS individual components

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in NAS individual components

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in fibrosis score

Time frame:Baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in Magnetic Resonance Imaging-determined Proton Density Fat Fraction (MRI-PDFF)

Time frame:Baseline to week 26 and week 52

MRI-PDFF, % change

change from baseline, improvement

Secondary/protocol endpoint

Improvement of fibrosis without worsening of hepatocyte ballooning component of NAS

Time frame:Week 52

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Assessment of pharmacokinetic (PK) parameter: AUC0-24

Time frame:Week 52

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameter: Cmax

Time frame:Week 52

Cmax

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameter: Ctrough

Time frame:Baseline to week 52

Plasma concentration (steady state)

concentration, descriptive

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.