NCT07521631

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-02-04
• Completion: 2027-07-23
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China