Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes
Recruiting
Phase 2
Interventional Study
Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 372 (estimated)
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender.
2. BMI ≥28.0 but \<40.0 kg/m2 at screening and randomization
3. Participants reported that they had been under diet and exercise control for 3 months or more before screening, and …
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