Actively Recruiting
Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-04-13
372
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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 Compared to Tirzepatide in Obese Adults Without Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years inclusive
- Body mass index (BMI) between 28.0 and less than 40.0 kg/m2
- Have been on diet and exercise control for 3 months or more before screening with less than 5% weight change during this period
- Fertile females must agree to use effective contraception from 14 days before signing consent to 60 days after last dose and have no plans to become pregnant or donate eggs
- Male participants must agree to use highly effective contraception from signing consent to 90 days after last dose and have no plans for fertility or sperm donation
You will not qualify if you...
- Previous diagnosis of any type of diabetes
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type
- Endocrine diseases or histories affecting gastric emptying or body weight, or diseases affecting absorption of gastrointestinal nutrients such as Cushing syndrome, thyroid disorders, past bariatric surgery, irritable bowel syndrome, dyspepsia, or chronic pancreatitis
- History of acute pancreatitis or acute gallbladder disease within 3 months before consent
- Unstable hypertension (systolic 2160 mmHg or diastolic 2100 mmHg) even with stable treatment
- Any malignant tumors within 5 years before consent except treated 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 215
- Known intolerance or allergy to study drug components or GLP-1 receptor agonists
- Use of weight loss or weight increasing drugs, hypoglycemic drugs, or participation in other clinical trials within 3 months before consent
- History of addictive drug abuse within 1 year before consent
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2
- Blood donation or loss of 400 mL or more within 3 months before consent, blood transfusion, or planned blood donation during study
- Pregnant or lactating women
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
L
Ling Tao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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