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NCT Number: NCT07036172

Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients

This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, China

Location status: Recruiting

Location contact

Linong Ji, Medical Doctor

CONTACT

[email protected]

+8601088324516

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent;
  • BMI ≥28 kg/m2;
  • A self-reported change in body weight no more than 5% within 90 days before screening.

Exclusion criteria

  • History of type 1 and type 2 diabetes;
  • Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
  • History or presence of chronic or acute pancreatitis;
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;
  • A history or presence of suspected depression or other mental disorders;
  • Patient Health Questionnaire-9 score of ≥15 at screening
  • Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening;
  • History of malignant neoplasms within the past 5 years prior to screening;

Treatment and study plan

HDM1702

Drug

Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.

Wegovy ®

Drug

Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.

Primary outcomes

  1. The percentage change in body weight from baseline to week 44

    Time frame: week 44

Secondary outcomes

  1. The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44

    Time frame: week 44

  2. Change in waist circumference, body weight and BMI at week 44

    Time frame: week 44

  3. Change in blood pressure and lipids at week 44

    Time frame: week 44

  4. Adverse events

    Time frame: week 44

  5. ADA and NAb

    Time frame: week 44

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

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.

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