A Study of IBI362 in Participants With Obesity or Overweight

Innovent Biologics

Status and phase: Completed; Phase 3

Conditions: Obesity Or Overweight

Treatments: Drug: IBI362; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607680

CIBI362B301

Details and patient eligibility

About

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.

Enrollment: 610 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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610 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo,SC,once a week for 48 weeks

Treatment:

Drug: Placebo

IBI362 4 mg

Experimental group

Description:

2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks

Treatment:

Drug: IBI362

IBI362 6 mg

Experimental group

Description:

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

Treatment:

Drug: IBI362