Efficacy of Mazdutide on Fatty Pancreas

NCT07803705 | Not Yet Recruiting

• 1 other identifier: nfm-GLP-1 RA -202601
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial designed to evaluate the efficacy and safety of mazdutide in improving fatty pancreas in patients with overweight or obesity. The study plans to enroll 194 participants with overweight or obesity, who will be randomly assigned in a 1:1 ratio to either the mazdutide plus standardized lifestyle intervention group or the placebo plus standardized lifestyle intervention group, for a treatment duration of 48 weeks. The primary efficacy endpoint is the change from baseline in pancreatic proton density fat fraction (PDFF) measured by MRI at week 48. Secondary efficacy endpoints include changes in body weight, body mass index (BMI), waist circumference, glycemic and lipid metabolic parameters, visceral fat, and hepatic fat content. This study aims to provide preliminary evidence-based data supporting the application of mazdutide in the treatment of fatty pancreas associated with metabolic dysfunction.

Conditions

Fatty Pancreas; Overweight; Obesity

Keywords

overweight or obesity; Fatty Pancreas; Mazdutide

Outcome Measures

Primary Outcomes (1)

• Percentage change in Intrapancreatic Fat Deposition (IPFD) from baseline

  The relative percentage change in IPFD measured by pancreatic MRI-PDFF at Week 48 compared to baseline, calculated as: \[(IPFDatWeek48-BaselineIPFD)/BaselineIPFD\] × 100%.

  From baseline to Week 48

Secondary Outcomes (13)

• Change in visceral fat area

  From baseline to Week 48

• Change in Body Mass Index (BMI)

  From baseline to Week 48

• Change in body weight

  From baseline to Week 48

• Change in waist circumference

  From baseline to Week 48

• Change in basal metabolic rate (BMR)

  From baseline to Week 48

Study Arms (2)

Intervention group

EXPERIMENTAL

standardized lifestyle intervention + mazdutide

Drug: mazdutide

Control group

PLACEBO COMPARATOR

standardized lifestyle intervention + placebo

Other: Placebo matching mazdutide

Interventions

mazdutide DRUG

On the basis of standardized lifestyle intervention, patients received mazdutide injection (prefilled auto-injector pen) via weekly subcutaneous injection (abdominal), following a dose-escalation regimen: an initial dose of 2 mg for weeks 1-4, escalation to 4 mg for weeks 5-8, and a maintenance dose of either 4 mg or 6 mg starting from week 9 (determined by tolerability and efficacy), with a treatment duration of 48 weeks.

Also known as: IBI-362; LY3305677

Intervention group

Placebo matching mazdutide OTHER

On the basis of standardized lifestyle intervention, patients received a placebo injection identical to mazdutide injection in appearance, volume, and administration route, via weekly subcutaneous injection (abdominal), with a treatment duration of 48 weeks.

Also known as: Placebo matching IBI-362

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients participating in this study must meet all of the following criteria:
• Age 18-60 years (inclusive) at screening, regardless of gender;
• BMI at screening meets one of the following conditions: ① BMI ≥28 kg/m²; or ② 24 kg/m² ≤ BMI \<28 kg/m², with at least one obesity-related metabolic abnormality (elevated fasting blood glucose, dyslipidemia, hypertension, etc.);
• Pancreatic MRI-PDFF quantitative assessment completed during the screening period, with intrapancreatic fat deposition (IPFD) ≥6%;
• Fully informed about the study and voluntarily signed written informed consent;
• Agreed to maintain a stable lifestyle (including diet and exercise habits) during the study.
• Note: Diagnostic criteria for Metabolic Syndrome (meeting ≥3 of the following items) \[ChineseDiabetesSociety(CDS)2020\]:
• Abdominal obesity (central obesity): Waist circumference ≥90 cm in men, ≥85 cm in women;
• Fasting blood glucose ≥6.1 mmol/L and/or 2-hour postprandial blood glucose ≥7.8 mmol/L, and/or diagnosed diabetes under treatment;
• Blood pressure ≥130/85 mmHg, and/or diagnosed hypertension under treatment;
• Fasting triglycerides (TG) ≥1.7 mmol/L;
• Fasting HDL-C \<1.04 mmol/L.

You may not qualify if:

• Participants meeting any of the following conditions will be excluded from this study:
• Glycated hemoglobin HbA1c ≥7.5% at screening; history of diabetic ketoacidosis (DKA) or other diabetic emergencies; Use within 3 months before screening of glucagon-like peptide-1 receptor (GLP-1R) agonists, GLP-1R/glucagon receptor (GCGR) dual agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, GIPR/GLP-1R/GCGR triple agonists, insulin, or oral antidiabetic drugs other than metformin; Use of any weight-loss drug or fat-reducing dietary supplement within 1 month before screening/enrollment; or use within 1 month before screening of systemic medications that may cause weight gain, including systemic glucocorticoids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers; Self-reported or documented weight fluctuation of \>5% within 3 months before screening; Current or history of acute pancreatitis or chronic pancreatitis; or serum triglycerides (TG) \>5.6 mmol/L at screening; or history of acute cholecystitis or symptomatic/requiring-treatment gallbladder disease (except participants who have undergone cholecystectomy and are judged by the investigator to be eligible); Chronic kidney disease stage 3 or higher, eGFR \<60 mL/min/1.73 m² (calculated by CKD-EPI formula); Obesity secondary to other endocrine diseases, such as Cushing syndrome; Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC); History of malignancy within 5 years before screening (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.); Acute myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 6 months before screening; or New York Heart Association (NYHA) class III or IV heart failure; Acute or chronic hepatitis at screening (except chronic hepatitis B), autoimmune hepatitis, or significantly abnormal liver function: ALT or AST \>3×ULN, or total bilirubin \>2×ULN (except Gilbert syndrome); History of pancreatic injury; imaging findings suggestive of pancreatic space-occupying lesion, pancreatic atrophy, pancreatic calcification, or history of pancreatic surgery that may affect IPFD assessment; Contraindications to MRI examination (e.g., metallic implants in the body, claustrophobia, etc.) or inability to cooperate with breath-holding for the examination; Blood amylase or lipase \>2×ULN at screening; Pregnant or lactating women, or positive pregnancy test at screening; women of childbearing potential who are unwilling to use medically accepted contraception during the study; Allergy to GLP-1 receptor agonists or any component of the study drug; or prior discontinuation of GLP-1 receptor agonist drugs due to safety or tolerability reasons; Participation in another interventional clinical trial within 3 months before screening; History of major depressive disorder, or current severe psychiatric illness (e.g., schizophrenia, bipolar disorder, etc.) judged by the investigator to be unable to comply with study procedures; History of conditions affecting gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, severe diabetic gastroparesis, etc.), long-term use of drugs directly affecting gastrointestinal motility, severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or prior gastrointestinal surgery (except surgeries with no significant effect on gastrointestinal motility, such as gastrointestinal polypectomy, appendectomy, and hemorrhoid surgery); Severe infection, severe trauma, or major or moderate surgery within 1 month before screening; Severe ECG abnormalities at screening (e.g., QTcF \>450 ms, supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), or poorly controlled blood pressure: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Additional laboratory criteria: alkaline phosphatase (ALP) ≥2×ULN; calcitonin ≥50 ng/L; thyroid-stimulating hormone (TSH) \<0.4 or \>6.0 mIU/L; hemoglobin \<100 g/L; Presence of acute or chronic hepatitis, or history of other severe liver diseases except metabolic-associated fatty liver disease; presence of significant hematologic diseases (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or diseases causing hemolysis/red blood cell instability; presence of autoimmune disease with planned systemic glucocorticoid or immunosuppressant therapy during the study; prior organ or bone marrow transplantation or planned transplantation during the trial; Known or suspected history of excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women for \>3 months), or history of drug abuse or illicit drug use; Any other condition that, in the investigator's opinion, may affect compliance or safety assessment.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

TongjHospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Yang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delin Ma

CONTACT

86-027 83665513; maderine4@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)