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RECRUITING
NCT07521631
PHASE2

Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes

Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a 56-week randomized, open-label, controlled study evaluating the efficacy and safety of the HDM1005 compared to tirzepatide in adults with obesity but without diabetes. Eligible participants will be screened and randomized to different dose group of HDM1005 or the tirzepatide group at a ratio of 1:1:1 :1, HDM1005 or tirzepatide will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

Official title: A Phase 2, Randomized, Open-Label, Controlled Trial to Evaluate the Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2026-03-31

Completion Date

2027-07-23

Last Updated

2026-04-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

HDM1005 dose level 1

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 1, the intervention will last for 52 weeks in total.

DRUG

HDM1005 dose level 2

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 2, the intervention will last for 52 weeks in total.

DRUG

HDM1005 dose level 3

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 3, the intervention will last for 52 weeks in total.

DRUG

Tirzepatide

Initiate at a once weekly dose of 2.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.

Locations (1)

Zhongshan Hoapital

Shanghai, China