Not yet recruitingPhase NA

Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide

Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide: A Multicenter, Prospective, Randomized Controlled Trial (IIT)

Lead sponsor

Tianjin Medical University

Assets

Mazdutide / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥24•HbA1c ≤7%

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07713992

Org study ID●JXYJNYYkMEC2026-32

Timeline

Milestones

Study first posted2026-07-20actual

Last update posted2026-07-20actual

Study start2026-09-15estimated

Primary completion2027-12-31estimated

Study completion2028-02-01estimated

Assets

Investigational agents

Mazdutide Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Aged between 18 and 60 years (inclusive) at the time of informed consent signing.

•Diagnosed with type 2 diabetes mellitus.

•Received once-weekly semaglutide 1.0 mg treatment for at least 16 consecutive weeks verified by medication records.

•Diagnosed with moderate-to-severe fatty liver, defined as hepatic attenuation ≥269 dB/m by transient elastography and hepatic fat fraction >10% measured by MRI-PDFF.

•HbA1c level <7%.

•Body mass index (BMI) ≥24 kg/m².

•Glycemic and weight management regimens without adjustments within 3 months prior to screening.

•Voluntarily signed written informed consent and agreed to comply with the study protocol.

Exclusion criteria

•History of alcoholic fatty liver, drug-induced fatty liver, viral hepatitis, autoimmune diseases, or acute gallbladder diseases.

•Use of medications affecting fatty liver metabolism within 3 months prior to screening, including but not limited to SGLT-2 inhibitors, vitamin E, GLP-1R/GIPR agonists, liver-selective thyroid receptor β agonists, PPAR agonists, and aspirin.

•Use of weight-loss drugs or alternative weight-loss therapies within 3 months prior to screening.

•Addition to sulfonylureas, glinides, dorzagliatin, or various insulin preparations within 3 months prior to screening.

•History of bariatric surgery or planned bariatric surgery during the study (excluding acupuncture, liposuction and abdominal liposuction performed more than 1 year before screening).

•Diagnosed with type 1 diabetes or latent autoimmune diabetes in adults.

•Personal history of acute or chronic pancreatitis, personal or family history of medullary thyroid carcinoma (MTC), or family history of multiple endocrine neoplasia type 2 (MEN2).

•Presence of severe cardiovascular, cerebrovascular, hepatic or renal insufficiency, uncontrolled diabetes, malignancy, cirrhosis or advanced liver fibrosis.

•Pregnant or lactating females, those planning pregnancy within half a year, or with recent major surgery or severe infection.

•Mental disorders or cognitive disorders that may interfere with study compliance, or any other conditions judged inappropriate for study participation by the investigator.

•Contraindications to MRI examination, including implantation of pacemakers, metallic heart valves, magnetic surgical clips, implantable electronic infusion pumps, severe claustrophobia, or inability to tolerate MRI scanning.

Endpoints (0)

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.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.