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Recruiting Phase 2 NCT06886126

Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus

Trial Parameters

Condition Obesity
Sponsor Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-02-07
Completion 2025-09-23
Interventions
HDM1005 injection or placebo

Brief Summary

It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HDM1005 injection in nondiabetic obese adults.

Eligibility Criteria

Inclusion Criteria: 1\. The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender. 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 their weight change (the difference between the maximum body weight and the minimum body weight) in the past 3 months was less than 5%. (4) fertile female subjects who have taken and agreed to continue to take effective contraceptive measures from 14 days before signing ICF to 60 days after the last dose, and have no plans to give birth and donate eggs; Male subjects signed ICF until 90 days after the last dose, had no fertility plan and sperm donation plan, and agreed to use highly effective contraception. Exclusion Criteria: 1. Previous diagnosis of type 1, type 2, or any other type of diabetes. 2. History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endoc

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