Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial

NCT07767552 | Not Yet Recruiting

• 1 other identifier: 2026-0810
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate and efficacy of Mastitide for diabetes remission in Chinese type 2 diabetic subjects with poor glycemic control on diet or exercise therapy alone or metformin/sodium-glucose cotransporter (SGLT2) inhibitor monotherapy.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44

  Baseline, 44 weeks

Secondary Outcomes (5)

• HbA1c change from baseline at week 32

  Baseline, 32 weeks

• Change from Baseline in Fasting Plasma Glucose

  Week 32

• Percent Change from Baseline in Body Weight

  Week 32

• Proportion of Participants Maintaining HbA1c<7.0% and achieving ≥5% Body Weight Reduction at Week 32

  Week 32

• HbA1c Normalization Rate (HbA1c ≤6.5%)

  Week 32

Study Arms (2)

Mazdutide 6 mg

EXPERIMENTAL

①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks； ③6mg, SC, once a week\* 40weeks.

Drug: Mazdutide

placebo

PLACEBO COMPARATOR

placebo, SC, once a week\* 32weeks;

Drug: Placebo

Interventions

Mazdutide DRUG

GLP-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist, administered by subcutaneous injection once weekly using a pre-filled pen device. Titration from 2 mg QW (weeks 0-4) to 4 mg QW (weeks 5-8) to 6 mg QW (weeks 9-24). Injection sites: abdomen, anterior-lateral thigh, or lateral upper arm, rotated at each injection.

Mazdutide 6 mg

Placebo DRUG

Matching placebo for mazdutide, administered by subcutaneous injection once weekly using a pre-filled pen device identical in appearance, color, volume, and packaging to the active drug pen. Titration schedule mirrors the 6 mg mazdutide arm to maintain blinding.

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2D was diagnosed according to WHO standards in 1999. 2.18 years to 70years when signing the informed consent form. 3.Diet and exercise intervention alone before screening, or stable metformin (≥500 mg/ day and ≤2000mg/ day for at least 4 weeks), or a stable dose of SGLT2 inhibitor (minimum maintenance dose: Empagliflozin 10 mg/ day, dapagliflozin 5 mg/ day, canagliflozin 100 mg/ day, constant agliflozin 5 mg/ day, and etoagliflozin 5 mg/ day for at least 4 weeks) were still not well controlled after monotherapy, and the local laboratory test at screening was 6.5%≤HbA1c≤9.0%.
• Duration of type 2 diabetes ≤5 years at screening. 5.BMI≥24 kg/m2 at screening. 6.A stable diet and exercise lifestyle could be maintained during the study period.
• Subjects voluntarily sign informed consent and agree to strictly follow the requirements of this protocol.

You may not qualify if:

• \. Subjects who are considered by the investigator to be potentially allergic to the components of the study drug or to the drug in the same class.
• Weight change \> 5% in 12 weeks before screening (chief complaint). 3. Use of any of the following drugs or treatments before screening:
• Use of a GLP-1R agonist or GLP-1R/GCGR (glucagon receptor) agonist or GIPR (glucose-dependent insulinotropic polypeptide) within 2 months before screening receptor) /GLP-1R agonist or GIPR/GLP-1R/GCGR agonist; Participants who discontinued a drug more than 2 months before screening because of lack of efficacy or intolerance were also excluded.
• Oral antidiabetic drugs other than background medications within 2 months before screening.
• Use of insulin for diabetes control within 3 months before screening, except for short-term use of insulin in acute conditions (cumulative ≤14 days), such as acute illness, hospitalization, or elective surgery. The interval between the last insulin treatment and screening day was less than 14 days.
• Weight-loss medications used within 1 month before screening or planned to be used during the trial, such as semaglutide, benaglutide, liraglutide, orlistat, sibutramine hydrochloride, phenylpropanolamine, chlorbendazole, phenylbutamine, lorcaserin hydrochloride, phentermine, phentermine/topiramate, bupropion, and naltrexone/bupropion.
• Use of Chinese herbal medicine, other traditional medicines and health products with hypoglycemic effect within 2 months before screening.
• were receiving chronic (\> 2 weeks) systemic glucocorticoids or had received glucocorticoids within 4 weeks before screening (topical, intraocular, intranasal, or inhaled administration were excluded).
• current use of central nervous system stimulants, excluding caffeinated beverages, at the time of screening.
• have participated in another clinical trial and received a trial drug within 3 months before screening.
• History of alcohol and drug abuse at screening. Mean weekly alcohol intake: more than 21 units for men and 14 units for women (1 unit = 360 ml of beer, or 150 ml of red wine, or 45 ml of distilled/liquor).
• \. There is a history or evidence of any of the following diseases:
• Previously diagnosed with type 1 diabetes (including latent autoimmune diabetes in adults, LADA), or positive for glutamic acid decarboxylase antibody (GADA) and other islet-related antibodies.
• Complications of diabetes occurred within 30 days before screening (ketosis acidosis, hyperosmolar diabetic state, or lactic acidosis).
• History of severe hypoglycemic episodes within 30 days before screening, defined as presenting with neurological hypoglycemic symptoms and requiring assistance from others to recover, or having no awareness of hypoglycemia or insufficient understanding of hypoglycemic symptoms in the past. Subjects who the researchers consider unable to communicate and understand hypoglycemic symptoms and appropriate treatment should also be excluded from this study.

Sponsors & Collaborators

• Yanbing Li: lead

Study Sites (1)

Sun Yat-sen University (Responsible Party)

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yanbing Li, MD, PhD

CONTACT

020-87755766; liyb@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)