Skip to main content
OpenTrials
Completed

NCT Number: NCT05607680

A Study of IBI362 in Participants With Obesity or Overweight

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity or Overweight

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xuancheng People's Hospital, Xuancheng, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo administered subcutaneously (SC) once a week.

IBI362

Drug

IBI362 administered subcutaneously (SC) once a week.

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 32

  2. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Time frame: Week 32

Secondary outcomes

  1. Percentage of Participants who Achieve ≥10%Body Weight Reduction

    Time frame: Week 32,Week 48

  2. Percentage of Participants who Achieve ≥15% Body Weight Reduction

    Time frame: Week 32,Week 48

  3. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 32,Week 48

  4. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 48

  5. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Time frame: Week 48

  6. Percentage of Participants who Achieve ≥20% Body Weight Reduction

    Time frame: Week 32, Week 48

  7. Change from Baseline in Neck Circumference

    Time frame: Baseline, Week 32, Week 48

  8. Change from Baseline in Hip Circumference

    Time frame: Baseline, Week 32, Week 48

  9. Change from Baseline in Body Weight

    Time frame: Baseline, Week 32, Week 48

  10. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 60

  11. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 32, Week 48

  12. Percentage of Participants with BMI < 24 kg/m2

    Time frame: Week 32, Week 48

  13. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 32, Week 48

  14. Change from Baseline in Diastolic Blood Pressure

    Time frame: Baseline, Week 32, Week 48

  15. Change from Baseline in Triglyceride

    Time frame: Baseline, Week 32,Week 48

  16. Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 32, Week 48

  17. Change from Baseline in Low-density Lipoprotein Cholesterol

    Time frame: Baseline, Week 32, Week 48

  18. Change from Baseline in High-density Lipoprotein Cholesterol

    Time frame: Baseline, Week 32, Week 48

  19. Change from Baseline in Serum Uric Acid

    Time frame: Baseline, Week 32, Week 48

  20. Change from Baseline in Alanine Aminotransferase

    Time frame: Baseline, Week 32, Week 48

  21. Change from Baseline in Aspartate Aminotransferase

    Time frame: Baseline, Week 32, Week 48

  22. Change from Baseline in Glycated Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 32, Week 48

  23. Change from Baseline in Fasting Plasma Glucose

    Time frame: Baseline, Week 32, Week 48

  24. Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 32, Week 48

  25. Change from Baseline in Fasting C-peptide

    Time frame: Baseline, Week 32, Week 48

  26. Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)

    Time frame: Baseline, Week 32, Week 48

  27. Change from Baseline in IWQoL-Lite-CT Questionnaire Scores

    Time frame: Baseline, Week 32, Week 48

  28. Change from Baseline in SF-36v2 Questionnaire Scores

    Time frame: Baseline, Week 32, Week 48

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.