Actively Recruiting
Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-09-30
240
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Body mass index (BMI) between 28.0 and less than 40.0 kg/m2 at screening and randomization
- Have been controlling weight with diet and exercise for 3 months or more before screening
- Weight change in past 3 months less than 5%
- Fertile females must use effective contraception from 14 days before signing consent to 60 days after last dose and have no plans to get pregnant or donate eggs
- Male participants must agree to use highly effective contraception from signing consent until 90 days after last dose with no plans for fertility or sperm donation
You will not qualify if you...
- Diagnosis of type 1, type 2, or other diabetes
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2
- Endocrine diseases or conditions affecting gastric emptying or nutrient absorption, including Cushing syndrome, thyroid disorders, bariatric surgery, irritable bowel syndrome, dyspepsia, chronic pancreatitis, or recent acute pancreatitis or gallbladder disease
- Cardiovascular or cerebrovascular events within 6 months before randomization, including unstable angina, severe heart failure, myocardial infarction, coronary interventions, severe arrhythmias, or stroke
- Uncontrolled hypertension at screening (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Malignant tumors within 5 years (except cured basal cell carcinoma)
- Severe infection, trauma, or major surgery within 3 months before consent or planned surgery during study (except outpatient surgery)
- History or suspicion of depression or psychiatric disorders or PHQ-9 score ≥15
- Known allergy or intolerance to study drug components or GLP-1 receptor agonists
- Use of weight loss or weight gain drugs/products within 3 months before consent
- Use of hypoglycemic drugs within 3 months before consent
- Participation in other clinical trials recently or within 5 half-lives of investigational drugs
- History of addictive drug abuse within 1 year before consent
- Abnormal lab tests including low hemoglobin, elevated liver enzymes, high triglycerides, abnormal glucose or HbA1c, abnormal calcitonin or thyroid stimulating hormone, elevated amylase or lipase, low kidney function, positive hepatitis or syphilis tests, or positive HIV antibodies
- Alcohol abuse within 1 year before consent
- Significant blood loss or transfusions recently or planned blood donation during study
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
Y
Yu Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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