ObesityPhase 3NCT06164873
A Study of IBI362 9 mg in Chinese Adults With Obesity
A Phase 3 study testing IBI362 in people with Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2023to 19 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years or older at the time of signing informed consent
- Have a BMI ≥30 kg/m2
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
- For subjects with T2D at screening:
- Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening
- Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening
- HbA1c 7.0-10.0% (both inclusive) at screening
- Fasting blood glucose ≤11.1 mmol/L at screening
Who cannot join
- A self-reported change in body weight above 5% within 3 months before screening
- For subjects without T2D at screening:
- HbA1c ≥6.5% as measured by local laboratory at screening
- For subjects with T2D at screening:
- Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment
- Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
- Conditions
- Obesity
- Being tested
- IBI362, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI362Drug
Once-weekly injections of gradually increased doses of IBI362
PlaceboDrug
Once-weekly injections of volume-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| IBI362 | Experimental | Not described Receives: Drug: IBI362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Measured: Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction
Measured: Week 60
Secondary outcomes (8)
Proportion of Participants who Achieve ≥10% Body Weight Reduction
Measured: Week 60
Proportion of Participants who Achieve ≥15% Body Weight Reduction
Measured: Week 60
Proportion of Participants who Achieve ≥20% Body Weight Reduction
Measured: Week 60
Change from Baseline in Waist Circumference
Measured: Week 60
Change from Baseline in Systolic Blood Pressure
Measured: Week 60
Percent Change from Baseline in Triglycerides
Measured: Week 60
Percent Change from Baseline in non-high-density lipoprotein cholesteroal
Measured: Week 60
Percent Change from Baseline in low-density lipoprotein cholesterol
Measured: Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start27 Dec 2023
- Primary completion27 Jun 2025 (estimated)
- Study completion19 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164873
- Sponsor's protocol ID
- CIBI362B302
- Status last verified
- Aug 2024
- First submitted
- 1 Dec 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, Han J, Zhang S, Pang S, Bi Y, Chen L, Gu X, Han J, Ma Q, Deng H, Wang Y, Li L, Han-Zhang H, Qian L, Ji L; GLORY-2 Trial Investigators. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):377-388. doi: 10.1001/jama.2026.8142.
PubMed 42251595
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)
- ClinicalTrials.gov ID
- NCT06164873
- Acronym / sponsor ID
- CIBI362B302
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 27 Jun 2025 (estimated)
- Study completion
- 19 Sep 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| IBI362 | Experimental | Drug: IBI362 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age 18 years or older at the time of signing informed consent
- Have a BMI ≥30 kg/m2
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
- Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening
- Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening
Key exclusion criteria (6 listed)
- A self-reported change in body weight above 5% within 3 months before screening
- HbA1c ≥6.5% as measured by local laboratory at screening
- Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment
- Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;
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 |
|---|---|---|
| IBI362Once-weekly injections of gradually increased doses of IBI362 | Drug | IBI362 |
| PlaceboOnce-weekly injections of volume-matched placebo | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction
Time frame: Week 60
8 secondary outcomes
Proportion of Participants who Achieve ≥10% Body Weight Reduction
Time frame: Week 60
Proportion of Participants who Achieve ≥15% Body Weight Reduction
Time frame: Week 60
Proportion of Participants who Achieve ≥20% Body Weight Reduction
Time frame: Week 60
Change from Baseline in Waist Circumference
Time frame: Week 60
Change from Baseline in Systolic Blood Pressure
Time frame: Week 60
Percent Change from Baseline in Triglycerides
Time frame: Week 60
Percent Change from Baseline in non-high-density lipoprotein cholesteroal
Time frame: Week 60
Percent Change from Baseline in low-density lipoprotein cholesterol
Time frame: Week 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42251595Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, Han J, Zhang S, Pang S, Bi Y, Chen L, Gu X, Han J, Ma Q, Deng H, Wang Y, Li L, Han-Zhang H, Qian L, Ji L; GLORY-2 Trial Investigators. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):377-388. doi: 10.1001/jama.2026.8142.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI362 in people with Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Weight (time frame: Week 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06164873, which also lists 1 linked publication.
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 27 Aug 2024.