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Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Phase II Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Obese Nondiabetic Adult Subjects

NCT06886126•Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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 endocrine neoplasia type 2.
•3. According to the investigator's judgment, the subjects have endocrine diseases or histories that affect gastric emptying, may significantly affect body weight, or diseases or conditions that affect the absorption of gastrointestinal nutrients, such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
•4. The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization:
•1. Unstable angina pectoris;
•2. cardiac insufficiency (New York Heart Association \[NYHA\] class III or IV);
•3. Myocardial infarction;
•4. Coronary artery bypass grafting or percutaneous coronary intervention;
•5. Severe arrhythmias such as sick sinus syndrome, second or third degree atrioventricular block;
•6. Cerebrovascular accidents, such as cerebral infarction, transient ischemic attack, etc.
+23 more criteria

Locations (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Key Dates

Start Date

February 7, 2025

Primary Completion Date

September 23, 2025

Completion Date

November 30, 2025

Last Updated

September 30, 2025

Enrollment

240

ESTIMATED participants

Conditions

Obesity

Interventions

HDM1005 injection or placebo

DRUG

Contacts

Yu Zhao

CONTACT

+86 16621373277 cxyzhaoyu@eastchinapharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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