Actively Recruiting
Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-12-12
825
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo 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
Official Title
Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years or older at the time of signing informed consent.
- Body mass index (BMI) of 28 kg/m2 or higher, or BMI of 24 kg/m2 or higher with at least one weight-related health issue such as hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, or weight-bearing joint pain.
- Body weight has not changed by more than 5% in the 90 days before screening.
- Able to understand and agree to follow the study procedures and willing to sign informed consent.
You will not qualify if you...
- Have type 1 or type 2 diabetes mellitus.
- HbA1c of 6.5% or higher, or fasting serum glucose of 7.0 mmol/L or higher at the first visit.
- Obesity caused by other hormone-related disorders or medications.
- Use of GLP-1 receptor agonists or similar drugs within 3 months before screening.
- Use of blood sugar-lowering drugs within 3 months before screening.
- History of thyroid C-cell cancer, multiple endocrine neoplasia types 2A or 2B, or relevant family history.
- Past acute or chronic pancreatitis, or gallbladder disease except removal surgery.
- PHQ questionnaire score of 15 or higher at screening or randomization.
- History of moderate to severe depression or severe mental illness.
- Uncontrolled high blood pressure defined as systolic ≥160 mmHg or diastolic ≥100 mmHg unless stable for 1 month with medication.
- History of cancer (except cured basal cell carcinoma) in the past 5 years or currently.
- History of serious heart or brain blood vessel disease in the last 6 months.
- History of alcohol or drug abuse.
- Allergy to the study drug or similar medications.
- Pregnant or breastfeeding women, or males or females not willing to use contraception.
- Any other condition that could affect study safety or results as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hoapital
Shanghai, China
Actively Recruiting
Research Team
H
Hui Qiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here