A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Conditions

• Overweight/ Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• IBI362 — DRUG
  IBI362 administered subcutaneously (SC) once a week.
• placebo — OTHER
  placebo administered subcutaneously (SC) once a week.

Study Details

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other. In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI \< 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control. The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.

Key Dates

Start date

Jun 8, 2021

Status verified

Nov 2025

Primary completion

Mar 29, 2023

Completion

Dec 6, 2023

Study Design

Enrollment

328 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IBI362 high dose
  high dose IBI362 administered subcutaneously (SC) once a week.
• Experimental: IBI362 low dose
  Low dose IBI362 administered subcutaneously (SC) once a week.
• Placebo Comparator: placebo
  placebo administered subcutaneously (SC) once a week.
• Experimental: IBI362 moderate dose
  moderate dose IBI362 administered subcutaneously (SC) once a week.
• Experimental: IBI362 extra high dose
  extra high dose IBI362 administered subcutaneously (SC) once a week.

Primary Outcome Measure

Percent Change from Baseline in Body Weight [ Time Frame: Baseline ,week 24 ]