A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

NCTNCT06184568Other idCIBI362A303

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 349 participants (actual)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 29 Feb 2024
Primary completion: 17 Sept 2025
Completion: 9 Feb 2026
First posted: 28 Dec 2023
Last update posted: 11 Jun 2026
Conditions: Type 2 Diabetes · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 3
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
NCT06184568
29 Feb 2024 to 9 Feb 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

IBI362Drug
SemaglutideDrug

Arms2

Active comparator
Semaglutide
Experimental
IBI362

Primary outcomes1

Outcomes the sponsor listed as primary.

Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss
Time frame · Week 32

Secondary outcomes(20)

Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss
Time frame · Week 32
Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss
Time frame · Week 32
Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss
Time frame · Week 32
Change from Baseline in HbA1c
Time frame · Week 32
Change in fasting plasma glucose(FPG) from baseline
Time frame · Week 32
Change in 7-point self-monitored blood glucose(SMBG) from baseline
Time frame · Week 32
Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7%
Time frame · Week 32
Change in body weight from baseline
Time frame · Week 32
Percent change in body weight from baseline
Time frame · Week 32
Change in waist circumference from baseline
Time frame · Week 32
Change in body mass index (BMI) from baseline
Time frame · Week 32
Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15%
Time frame · 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
Time frame · Week 32
Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline
Time frame · 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
Time frame · Week 32
Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline
Time frame · Week 32
Change in serum uric acid from baseline
Time frame · Week 32
Change in quality of life (IWQoL-Lite-CT) from baseline
Time frame · Week 32
Change in quality of life (SF-36 v2) from baseline
Time frame · Week 32
Change in HOMA2-β from baseline
Time frame · Week 32

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.