A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity (NCT06184568) | Clinical Trial Compass
CompletedPhase 3
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
China349 participantsStarted 2024-02-29
Plain-language summary
This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-week drug withdrawal safety follow-up period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, age 18 years or older at the time of signing informed consent
* T2D was diagnosed according to WHO standards in 1999(≤5 years)
* The blood glucose was not well controlled after diet and exercise with/without sable metformin(≥1500mg/day，no more than 2550mg/day) within 3 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤9.5% during screening
* Have a BMI ≥28 kg/m2
Exclusion Criteria:
* Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
* A self-reported change in body weight above 5% within 3 months before screening
* Oral hypoglycemic drugs other metformin have been used within 2 months before screening.
* Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
* There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
* Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
* Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
* The investigator believes that the subject has any other factors that may affe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared IBI362 to semaglutide specifically in Chinese adults with early type 2 diabetes and obesity — does my own background, disease stage, and weight profile closely match the kind of patients who were enrolled, and would those results likely apply to me?
2The main goal of this trial was whether patients could reach both an HbA1c below 7.0% AND lose at least 10% of their body weight at the same time — based on my current HbA1c and weight, is that kind of combined target realistic for me, and how does IBI362 compare to semaglutide in how well it achieved that?
3Since this is a completed Phase 3 trial, what do the results actually show about the safety profile of IBI362 compared to semaglutide, and are there side effects I should be specifically aware of given my health history?
4Semaglutide is already an approved medication I might be able to access today — given that this trial used semaglutide as the comparison drug, would my doctor recommend I consider semaglutide now rather than waiting to see if IBI362 becomes available?
5This trial was conducted in Chinese adults — is there any reason the findings might or might not translate to my situation, and is IBI362 currently approved or available outside of a clinical trial setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss