Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: liver, addiction
- Who it enrolls
- age 18 Years to 60 Years; BMI ≥24 required; non-obese participants included; conditions: Type 2 Diabetes Mellitus (T2DM); Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
- Interventions
- Mazdutide(Dual GLP-1R/GCGR Agonist); Semaglutide (1 Mg Dose)
- Conditions
- Type 2 Diabetes Mellitus (T2DM); Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
- Phase and size
- NA · 72 participants
- Dates
- Start 2026-09-15
Primary completion 2027-12-31 - Sponsor
- Tianjin Medical University (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Absolute change in liver fat content measured by MRI-PDFFBaseline, Week 16, Week 32
- Absolute change in liver fat content measured by liver transient elastographyBaseline, Week 16, Week 32
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.