Obesity Or Overweight
Conditions
Brief 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. 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.
Interventions
DRUGPlacebo
Placebo administered subcutaneously (SC) once a week.
DRUGIBI362
IBI362 administered subcutaneously (SC) once a week.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 32 |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Week 32 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Waist Circumference | Baseline, Week 32,Week 48 |
| Percent Change from Baseline in Body Weight | Baseline, Week 48 |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Week 48 |
| Percentage of Participants who Achieve ≥20% Body Weight Reduction | Week 32, Week 48 |
| Change from Baseline in Neck Circumference | Baseline, Week 32, Week 48 |
| Change from Baseline in Hip Circumference | Baseline, Week 32, Week 48 |
| Change from Baseline in Body Weight | Baseline, Week 32, Week 48 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 32, Week 48 |
| Percentage of Participants with BMI < 24 kg/m2 | Week 32, Week 48 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 32, Week 48 |
| Change from Baseline in Diastolic Blood Pressure | Baseline, Week 32, Week 48 |
| Change from Baseline in Triglyceride | Baseline, Week 32,Week 48 |
| Percentage of Participants who Achieve ≥10%Body Weight Reduction | Week 32,Week 48 |
| Change from Baseline in Low-density Lipoprotein Cholesterol | Baseline, Week 32, Week 48 |
| Change from Baseline in High-density Lipoprotein Cholesterol | Baseline, Week 32, Week 48 |
| Change from Baseline in Serum Uric Acid | Baseline, Week 32, Week 48 |
| Change from Baseline in Alanine Aminotransferase | Baseline, Week 32, Week 48 |
| Change from Baseline in Aspartate Aminotransferase | Baseline, Week 32, Week 48 |
| Change from Baseline in Glycated Hemoglobin A1c (HbA1c) | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting Plasma Glucose | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting Insulin | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting C-peptide | Baseline, Week 32, Week 48 |
| Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR) | Baseline, Week 32, Week 48 |
| Change from Baseline in IWQoL-Lite-CT Questionnaire Scores | Baseline, Week 32, Week 48 |
| Change from Baseline in SF-36v2 Questionnaire Scores | Baseline, Week 32, Week 48 |
| Change from Baseline in Total Cholesterol | Baseline, Week 32, Week 48 |
| Percentage of Participants who Achieve ≥15% Body Weight Reduction | Week 32,Week 48 |
Countries
China
Outcome results
None listed