A Phase 2 interventional study of Mazdutide(Dual GLP-1R/GCGR Agonist) and Placebo in Obesity, Overweight and Atypical Endometrial Hyperplasia, sponsored by Tongji Hospital. Not yet recruiting at 6 sites in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Tongji Hospital · Phase 2, Interventional, and Treatment
Among 22 studies testing mazdutide in Obesity — 11 open to participants now, 14 under way, 4 of them phase 3. mazdutide · Obesity.
Among the 22 studies testing mazdutide in Obesity, this one is the 15th largest by planned enrollment, is one of 8 that started in 2026, is one of 5 in phase 2, reaches primary completion later than 13 of the 13 other live ones, and was the 19th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 128 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →11 of the 22 studies testing mazdutide in Obesity are open now, in 3 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →On this site’s reading of the record, mazdutide is the treatment under test here. Read study by study →
22 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 8 started in 2026.
Median enrollment 187 across the 22 interventional studies. Of the 8 that completed or were terminated, 1 (13%) have results posted.
15 of 22 have an industry lead sponsor. The 8 most frequent:
Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.
Tongji Hospital has 2 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
3 of the studies testing mazdutide in Obesity that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06931028Phase 3Innovent Biologics (Suzhou) Co. Ltd.A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2 | 2027-05-07 |
| NCT07255209Phase 3Innovent Biologics (Suzhou) Co. Ltd.A Study of IBI362 in Chinese Adolescents With Obesity or Overweight | 2027-10-31 |
| NCT06143956Eli Lilly and CompanyA Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight | 2027-09 |
Among the 22 studies testing mazdutide in Obesity, from their registry updates:
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of mazdutide combined with a levonorgestrel-releasing intrauterine system (LNG-IUS) for fertility-sparing treatment in overweight or obese patients with atypical endometrial hyperplasia (AEH) or early-stage endometrioid endometrial cancer. Eligible participants will be randomized in a 1:1 ratio to receive LNG-IUS plus mazdutide or LNG-IUS plus matching placebo. The primary outcome is the complete response rate of endometrial lesions at 24 weeks after randomization.
Eligible participants are premenopausal women with a strong desire to preserve fertility, diagnosed with AEH or FIGO grade 1 early-stage endometrioid endometrial cancer confined to the endometrium, and with overweight or obesity. All participants will receive LNG-IUS. Participants will be randomized 1:1 to receive either mazdutide or matching placebo by subcutaneous injection once weekly, using a dose-escalation regimen. Endometrial response will be assessed by hysteroscopic endometrial biopsy and pathology evaluation at prespecified time points. The study will compare pathological response, time to complete response, safety, body weight and metabolic changes, reproductive endocrine parameters, subsequent pregnancy outcomes, recurrence, patient-reported outcomes, and exploratory biomarker changes between the two treatment groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive LNG-IUS placed in the uterine cavity and mazdutide by subcutaneous injection once weekly using a dose-escalation regimen.
Drug: Mazdutide(Dual GLP-1R/GCGR Agonist) · Device: Levonorgestrel-releasing intrauterine system
Participants will receive LNG-IUS placed in the uterine cavity and matching placebo by subcutaneous injection once weekly using the same dose-escalation schedule as the mazdutide group.
Drug: Placebo · Device: Levonorgestrel-releasing intrauterine system
Drug page: Mazdutide
Mazdutide will be administered by subcutaneous injection once weekly. The starting dose is 2 mg once weekly for weeks 1-4, followed by 4 mg once weekly for weeks 5-8, and 6 mg once weekly from week 9 onward. If 6 mg is not tolerated, the dose may be reduced to 4 mg once weekly according to the protocol.
Also known as: IBI362
Matching placebo will be administered by subcutaneous injection once weekly using the same injection route, frequency, injection volume, appearance, packaging, labeling, injection device, and dose-escalation procedure as mazdutide.
The levonorgestrel-releasing intrauterine system will be placed in the uterine cavity according to standard clinical practice and will be used as the background fertility-sparing progestin therapy in both treatment groups.
Also known as: LNG-IUS
Complete response rate of endometrial lesions at 24 week
The proportion of participants who achieve complete response of endometrial lesions at the week 24 assessment. Complete response is defined as no residual AEH or endometrioid endometrial cancer on evaluable endometrial pathology obtained by hysteroscopic endometrial biopsy.
Time frame: At 24 weeks after randomization
Complete response rate at 12 weeks
The proportion of participants who achieve complete response at the week 12 pathological assessment.
Time frame: At 12 weeks after randomization
Complete response rate at 36 weeks
The proportion of participants who achieve complete response at the week 36 pathological assessment.
Time frame: At 36 weeks after randomization
Time to first complete response
Time from randomization to the date of the first pathological assessment confirming complete response.
Time frame: From randomization to first documented complete response, up to 36 weeks
Pathological response status
Distribution of pathological response categories, including complete response, partial response, stable disease, progressive disease, and unevaluable specimens.
Time frame: At 12, 24, and 36 weeks after randomization
Fertility-sparing treatment failure and radical surgery
Proportion of participants who discontinue fertility-sparing treatment due to disease progression, persistent non-response, intolerance, or other oncologic reasons, and the proportion undergoing radical surgery.
Time frame: From randomization through the end of study follow-up, up to 2 years after complete response
Change in body weight
Change from baseline in body weight measured in kilograms.
Time frame: Baseline, 12 weeks, 24 weeks, and 36 weeks after randomization
Percentage change in body weight
Percentage change from baseline in body weight, calculated as: \[(body weight at visit - baseline body weight) / baseline body weight\] × 100%.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Proportion of participants with at least 5% body weight reduction
The proportion of participants with body weight reduction of at least 5% from baseline. The outcome will be reported as a percentage of participants.
Time frame: At 12, 24, and 36 weeks after randomization
Proportion of participants with at least 10% body weight reduction
The proportion of participants with body weight reduction of at least 10% from baseline. The outcome will be reported as a percentage of participants.
Time frame: At 12, 24, and 36 weeks after randomization
Change in body mass index
Change from baseline in body mass index, measured in kg/m\^2.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in waist circumference
Change from baseline in waist circumference, measured in centimeters.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in fasting plasma glucose
Change from baseline in fasting plasma glucose, measured in mmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in HbA1c
Change from baseline in glycated hemoglobin, measured as percentage.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in fasting insulin
Change from baseline in fasting insulin, measured in μIU/mL or mIU/L according to the local laboratory standard.
Time frame: Baseline, 24 weeks, and at early discontinuation of study treatment if applicable
Change in HOMA-IR
Change from baseline in homeostatic model assessment of insulin resistance. HOMA-IR is calculated from fasting glucose and fasting insulin and is reported as a unitless index.
Time frame: Baseline, 24 weeks, and at early discontinuation of study treatment if applicable
Change in total cholesterol
Change from baseline in total cholesterol, measured in mmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in triglycerides
Change from baseline in triglycerides, measured in mmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in LDL cholesterol
Change from baseline in low-density lipoprotein cholesterol, measured in mmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in HDL cholesterol
Change from baseline in high-density lipoprotein cholesterol, measured in mmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in alanine aminotransferase
Change from baseline in alanine aminotransferase, measured in U/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in aspartate aminotransferase
Change from baseline in aspartate aminotransferase, measured in U/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Change in serum uric acid
Change from baseline in serum uric acid, measured in μmol/L.
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Plan to share: No — Individual participant data will not be publicly shared because the study involves sensitive reproductive, oncologic, genetic, and biomarker-related clinical information. De-identified data may be made available from the principal investigator upon reasonable request and after approval by the study steering committee and ethics committee, where applicable.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2029, 31 months later.
Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 31 months is below that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mazdutide