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

NCT07036172 | Recruiting Phase 3

• 1 other identifier: HDM1702-301
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity Control

Outcome Measures

Primary Outcomes (1)

• The percentage change in body weight from baseline to week 44

  week 44

Secondary Outcomes (5)

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

  week 44

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

  week 44

• Change in blood pressure and lipids at week 44

  week 44

• Adverse events

  week 44

• ADA and NAb

  week 44

Study Arms (2)

HDM1702

EXPERIMENTAL

Drug: HDM1702

WEGOVY®

ACTIVE COMPARATOR

Drug: Wegovy ®

Interventions

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.

HDM1702

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.

WEGOVY®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Male or female aged 18 years to 75 years (inclusive) at the time of signing the informed consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

semaglutide

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician, data manager and medical monitor are masked to the randomized allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: January 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CN (1)