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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase

Enrolling

Phase 3

Conditions

Obesity Control

Treatments

Drug: Wegovy ®

Drug: HDM1702

Study type

Interventional

Funder types

Industry

Identifiers

NCT07036172

HDM1702-301

Details and patient eligibility

About

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.

Enrollment

460 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;