Obesity Or OverweightPhase 3NCT05607680
A Study of IBI362 in Participants With Obesity or Overweight
A Phase 3 study testing IBI362 in people with Obesity Or Overweight, run by Innovent Biologics (Suzhou) Co. Ltd. at 23 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Or Overweight
- 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
- 610 participants
- Where
- 23 sitesChina
- Study dates
- 14 Nov 2022to 16 Apr 2024
- 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
- Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.
Who cannot join
- HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
- Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
- Have used or are currently using weight loss drugs within 3 months before screening;
- History of pancreatitis;
- Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
- History of moderate to severe depression or severe mental illness;
- Any lifetime history of a suicide attempt
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Huzhou Central Hospital
Huzhou, Zhejiang
Jinan Central Hospital
Ji'nan, Shandong
Shandong Provincial Third Hospital
Ji'nan, Shandong
The First People's Hospital Of Kunshan
Kunshan, Jiangsu
Hebei Petro China Central Hospital
Langfang, Hebei
Lishui Central Hospital
Lishui, Zhejiang
Luoyang Third People's Hospital
Luoyang, He'nan
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Affiliated Hospital Of Nantong University
Nantong, Jiangsu
The First Affiliated Hospital of Nanyang Medical University
Nanyang, He'nan
Pingxiang People's Hospital
Pingxiang, Jiangxi
Qilu Hospital Of Shandong University (Qingdao)
Qingdao, Shandong
Shenyang Fifth People's Hospital
Shenyang, Liaoning
Suzhou Municipal Hospital
Suzhou, Jiangsu
Tai'an Central Hospital
Tai’an, Shandong
Shanxi Bethune Hospital
Taiyuan, Shanxi
Yan'an University Xianyang Hospital
Xianyang, Shanxi
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, He'nan
Xuancheng People's Hospital
Xuancheng, Anhui
Zibo Municipal Hospital
Zibo, Shandong
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
- Conditions
- Obesity Or Overweight
- Being tested
- Placebo, IBI362
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo administered subcutaneously (SC) once a week.
IBI362Drug
IBI362 administered subcutaneously (SC) once a week.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo,SC,once a week for 48 weeks Receives: Drug: Placebo |
| IBI362 4 mg | Experimental | 2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks Receives: Drug: IBI362 |
| IBI362 6 mg | Experimental | 2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks 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: Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Measured: Week 32
Secondary outcomes (28)
Percentage of Participants who Achieve ≥10%Body Weight Reduction
Measured: Week 32,Week 48
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Measured: Week 32,Week 48
Change from Baseline in Waist Circumference
Measured: Baseline, Week 32,Week 48
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Measured: Week 48
Percentage of Participants who Achieve ≥20% Body Weight Reduction
Measured: Week 32, Week 48
Change from Baseline in Neck Circumference
Measured: Baseline, Week 32, Week 48
Change from Baseline in Hip Circumference
Measured: Baseline, Week 32, Week 48
Change from Baseline in Body Weight
Measured: Baseline, Week 32, Week 48
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 60
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 32, Week 48
Percentage of Participants with BMI < 24 kg/m2
Measured: Week 32, Week 48
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 32, Week 48
Change from Baseline in Diastolic Blood Pressure
Measured: Baseline, Week 32, Week 48
Change from Baseline in Triglyceride
Measured: Baseline, Week 32,Week 48
Change from Baseline in Total Cholesterol
Measured: Baseline, Week 32, Week 48
Change from Baseline in Low-density Lipoprotein Cholesterol
Measured: Baseline, Week 32, Week 48
Change from Baseline in High-density Lipoprotein Cholesterol
Measured: Baseline, Week 32, Week 48
Change from Baseline in Serum Uric Acid
Measured: Baseline, Week 32, Week 48
Change from Baseline in Alanine Aminotransferase
Measured: Baseline, Week 32, Week 48
Change from Baseline in Aspartate Aminotransferase
Measured: Baseline, Week 32, Week 48
Change from Baseline in Glycated Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 32, Week 48
Change from Baseline in Fasting Plasma Glucose
Measured: Baseline, Week 32, Week 48
Change from Baseline in Fasting Insulin
Measured: Baseline, Week 32, Week 48
Change from Baseline in Fasting C-peptide
Measured: Baseline, Week 32, Week 48
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)
Measured: Baseline, Week 32, Week 48
Change from Baseline in IWQoL-Lite-CT Questionnaire Scores
Measured: Baseline, Week 32, Week 48
Change from Baseline in SF-36v2 Questionnaire Scores
Measured: Baseline, Week 32, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start14 Nov 2022
- Primary completion21 Aug 2023
- Study completion16 Apr 2024
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 Obesity Or OverweightStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 610 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
- NCT05607680
- Sponsor's protocol ID
- CIBI362B301
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.
PubMed 40421736
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)
- ClinicalTrials.gov ID
- NCT05607680
- Acronym / sponsor ID
- CIBI362B301
- Conditions
- Obesity Or Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 7 Nov 2022 (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 III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,SC,once a week for 48 weeks |
| IBI362 4 mg | Experimental | Drug: IBI3622 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks |
| IBI362 6 mg | Experimental | Drug: IBI3622 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.
Key exclusion criteria (7 listed)
- HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
- Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
- Have used or are currently using weight loss drugs within 3 months before screening;
- History of pancreatitis;
- Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
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 |
|---|---|---|
| PlaceboPlacebo administered subcutaneously (SC) once a week. | Drug | Placebo |
| IBI362IBI362 administered subcutaneously (SC) once a week. | Drug | IBI362 4 mg, IBI362 6 mg |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time frame: Week 32
28 secondary outcomes
Percentage of Participants who Achieve ≥10%Body Weight Reduction
Time frame: Week 32,Week 48
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time frame: Week 32,Week 48
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 32,Week 48
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time frame: Week 48
Percentage of Participants who Achieve ≥20% Body Weight Reduction
Time frame: Week 32, Week 48
Change from Baseline in Neck Circumference
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Hip Circumference
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Body Weight
Time frame: Baseline, Week 32, Week 48
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 60
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 32, Week 48
Percentage of Participants with BMI < 24 kg/m2
Time frame: Week 32, Week 48
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Diastolic Blood Pressure
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Triglyceride
Time frame: Baseline, Week 32,Week 48
Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Low-density Lipoprotein Cholesterol
Time frame: Baseline, Week 32, Week 48
Change from Baseline in High-density Lipoprotein Cholesterol
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Serum Uric Acid
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Alanine Aminotransferase
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Aspartate Aminotransferase
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Glycated Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Fasting C-peptide
Time frame: Baseline, Week 32, Week 48
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)
Time frame: Baseline, Week 32, Week 48
Change from Baseline in IWQoL-Lite-CT Questionnaire Scores
Time frame: Baseline, Week 32, Week 48
Change from Baseline in SF-36v2 Questionnaire Scores
Time frame: Baseline, Week 32, Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 40421736Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.
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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.
23 sites 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 Or Overweight, run by Innovent Biologics (Suzhou) Co. Ltd. at 23 sites 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Baseline, Week 32). 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 NCT05607680, 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 12 Nov 2024.