Diabetes Mellitus, Type 2NCT07767552
Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
A study testing Mazdutide in people with Diabetes Mellitus, Type 2, run by Yanbing Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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%.
- 4.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.
- 7.Subjects voluntarily sign informed consent and agree to strictly follow the requirements of this protocol.
Who cannot join
- 1. 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.
- 2.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.
Show all 33Show fewer
- 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).
- 4. 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.
- Previous history of acute or chronic pancreatitis, or blood amylase or lipase > 2.0×upper limit of normal value (ULN) during the screening period, or fasting triglycerides ≥ 5.64 mmol/L (500 mg/dl).
- Previous history of gastroparesis or bariatric surgery, or clinically significant gastric emptying abnormalities as determined by the researcher.
- Previous proliferative diabetic retinopathy, or diabetic macular edema, or rapid progression of non-proliferative diabetic retinopathy or requiring urgent treatment.
- Acute or chronic hepatitis (except chronic hepatitis B), symptoms and signs of other liver diseases, or ALT > 3.0×ULN (ALT > 5.0×ULN for non-alcoholic fatty liver disease), or AST > 3.0×ULN, or total bilirubin (TBIL) > 2.0×ULN.
- Previous personal or family history of medullary thyroid carcinoma, patients with multiple endocrine neoplasia type 2, or serum calcitonin ≥ 50 ng/L (pg/mL), or thyroid function-related indicators TSH > 6 mIU/L or < 0.4 mIU/L.
- Hyperthyroidism or hypothyroidism confirmed by clinical assessment and/or abnormal thyroid stimulating hormone (TSH) as determined by clinical evaluation, except for subjects on stable thyroid hormone replacement therapy for at least 2 months with normal thyroid function and expected unchanged dosage throughout the study period.
- Previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea.
- Had a severe cardiovascular or cerebrovascular event within 3 months before screening.
- 12-lead ECG at screening shows a heart rate < 50 beats/min or > 100 beats/min, ECG indicates active heart disease, or the researcher considers the ECG abnormality at screening would interfere with the interpretation of ECG results during the subsequent follow-up, especially excluding QTcF > 500 ms.
- Poorly controlled hypertension, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; or had adjusted antihypertensive drugs (dose or type) within 30 days before screening; evidence of renal artery stenosis, or unstable blood pressure (including orthostatic hypotension, etc.).
- Had active or untreated malignant tumors within 5 years before screening, or in a clinical remission period (skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ, or papillary thyroid carcinoma with no recurrence after surgery, except for subjects without recurrence) during the screening period. 15) During the screening process, if the estimated glomerular filtration rate (eGFR) is less than 45 mL/min/1.73 m2, it is calculated using the CKD-EPI formula (see Appendix 2).
- 16) A history of atopic reactions (clinical manifestations of severe or multiple allergies), or a clinically significant history of multiple or severe drug allergies, or intolerance to topical glucocorticoids, or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme, linear immunoglobulin A dermatitis, toxic epidermal necrolysis, allergic reactions, angioedema or exfoliative dermatitis).
- 17) Evidence of previous or during the screening period human immunodeficiency virus (HIV) infection or positive HIV antibody, or hepatitis B (HBV) antibody, or hepatitis C (HCV) antibody, or positive syphilis antibody.
- 18) History of organ transplantation (except corneal transplantation), or preparing for organ transplantation.
- 19) During the screening process, the investigator considers that there is a serious active and uncontrolled physical condition or history that may place the participant at risk during the use of the study drug or interfere with the interpretation of the efficacy and safety data of this study.
- 20) A history of mental illness during the past or during the screening period, and the investigator considers that the participant is not suitable to participate in this study.
- 21) Within the previous 3 months, the blood donation volume and/or blood loss volume was ≥ 450 mL or there was bone marrow donation, blood transfusion or severe blood loss, or there was hemoglobinopathy, hemolytic anemia, sickle cell anemia, or the blood hemoglobin was < 110g/L (for males) or < 100g/L (for females) during the screening, or there were any other known factors that may interfere with the HbA1c test results; 5. Pregnant or lactating women, or men or women with reproductive capacity who are unwilling to use contraception throughout the study period until 8 weeks after the end of the study.
- 6. The investigator considers that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University (Responsible Party)
Guangzhou, Guangdong, 510000
Yanbing Li, MD, PhD, 020-87755667, liyb@mail.sysu.edu.cn
About this study
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.
Read the detailed description
This study is a 44-week, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 249 type 2 diabetes patients with overweight or obesity are randomized 2:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential diabetes remission effects of mazdutide on cognitive dysfunction in type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mazdutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazdutideDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mazdutide 6 mg | Experimental | ①2mg, SC, once a week* 4weeks;
②4mg, SC, once a week* 4weeks；
③6mg, SC, once a week* 40weeks. Receives: Drug: Mazdutide |
| placebo | Placebo comparator | placebo, SC, once a week* 32weeks; Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44
Measured: Baseline, 44 weeks
Secondary outcomes (5)
HbA1c change from baseline at week 32
Measured: Baseline, 32 weeks
Change from Baseline in Fasting Plasma Glucose
Measured: Week 32
Percent Change from Baseline in Body Weight
Measured: Week 32
Proportion of Participants Maintaining HbA1c<7.0% and achieving ≥5% Body Weight Reduction at Week 32
Measured: Week 32
HbA1c Normalization Rate (HbA1c ≤6.5%)
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767552
- Sponsor's protocol ID
- 2026-0810
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT07767552
- Acronym / sponsor ID
- 2026-0810
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Yanbing LiUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a 44-week, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 249 type 2 diabetes patients with overweight or obesity are randomized 2:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential diabetes remission effects of mazdutide on cognitive dysfunction in type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mazdutide 6 mg | Experimental | Drug: Mazdutide①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks； ③6mg, SC, once a week* 40weeks. |
| placebo | Placebo comparator | Drug: Placeboplacebo, SC, once a week* 32weeks; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.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%.
- 4.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.
- 7.Subjects voluntarily sign informed consent and agree to strictly follow the requirements of this protocol.
Key exclusion criteria (33 listed)
- 1. 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.
- 2.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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MazdutideGLP-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. | Drug | Mazdutide 6 mg |
| PlaceboMatching 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. | Drug | placebo |
Primary outcome
Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44
Time frame: Baseline, 44 weeks
5 secondary outcomes
HbA1c change from baseline at week 32
Time frame: Baseline, 32 weeks
Change from Baseline in Fasting Plasma Glucose
Time frame: Week 32
Percent Change from Baseline in Body Weight
Time frame: Week 32
Proportion of Participants Maintaining HbA1c<7.0% and achieving ≥5% Body Weight Reduction at Week 32
Time frame: Week 32
HbA1c Normalization Rate (HbA1c ≤6.5%)
Time frame: Week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mazdutide in people with Diabetes Mellitus, Type 2, run by Yanbing Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbing Li, MD, PhD (020-87755766, liyb@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44 (time frame: Baseline, 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.