Obesity, Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGIBI362
Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC)，starting dose is IBI362 2.0 mg, continuous After 4 weeks of administration, increase to IBI362 4.0 mg. After 4 weeks of continuous administration, continue to increase to IBI362.
DRUGSemaglutide
Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC)，starting dose is semaglutide 0.25mg, after 4 weeks of continuous administration, increase to semaglutide 0.5mg, after 4 weeks of continuous administration, continue Upgrade to semaglutide 1.0 mg for 24 weeks.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss | Week 32 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss | Week 32 |
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss | Week 32 |
| Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss | Week 32 |
| Change from Baseline in HbA1c | Week 32 |
| Change in fasting plasma glucose(FPG) from baseline | Week 32 |
| Change in 7-point self-monitored blood glucose(SMBG) from baseline | Week 32 |
| Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7% | Week 32 |
| Change in body weight from baseline | Week 32 |
| Percent change in body weight from baseline | Week 32 |
| Change in waist circumference from baseline | Week 32 |
| Change in body mass index (BMI) from baseline | Week 32 |
| Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15% | Week 32 |
| Proportion of patients achieving 24 kg/m 2≤ BMI < 28 kg/m 2 and 18.5 kg/m 2≤ BMI < 24 kg/m 2 | Week 32 |
| Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline | Week 32 |
| Change in lipids [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG)] from baseline | Week 32 |
| Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline | Week 32 |
| Change in serum uric acid from baseline | Week 32 |
| Change in quality of life (IWQoL-Lite-CT) from baseline | Week 32 |
| Change in quality of life (SF-36 v2) from baseline | Week 32 |
| Change in HOMA2-β from baseline | Week 32 |
| Change in HOMA2-IR from baseline | Week 32 |
Countries
China
Outcome results
None listed