> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-hdm1005-compared-to-tirzepatide-in-31503921-d788-419c-ba0d-4ce4d57a4b52 > Record changed: 2026-10-13 # Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes NCT07521631 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Participants 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Lead sponsor Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Start date 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Short title** Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Official title** A Phase 2, Randomized, Open-Label, Controlled Trial to Evaluate the Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Dates **Completion date** 2027-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **First posted** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Primary completion date** 2027-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Start date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Size and sites **Participants** 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Planned participants** 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Lead sponsor** Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Identifiers **Registry ID** NCT07521631 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **ClinicalTrials.gov ID** NCT07521631 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Outcomes ### Primary outcomes 1. Primary Outcome Timeframe: week 40 The percentage change in body weight from baseline to week 40 ### Secondary outcomes 1. Secondary Outcome Timeframe: week 40 The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 40 2. Secondary Outcome Timeframe: week 52 The percentage change in body weight from baseline to week 52 3. Secondary Outcome Timeframe: week 40 Change in waist circumference at week 40 4. Secondary Outcome Timeframe: week 40 Change in body weight at week 40 5. Secondary Outcome Timeframe: week 40 Change in BMI at week 40 6. Secondary Outcome Timeframe: week 52 Change in BMI at week 52 7. Secondary Outcome Timeframe: week 52 Change in waist circumference at week 52 8. Secondary Outcome Timeframe: week 52 Change in waist body weight at week 52 9. Secondary Outcome Timeframe: week 40 Change in systolic blood pressure (SBP) at week 40 10. Secondary Outcome Timeframe: week 40 Change in diastolic blood pressure (DBP) at week 40 11. Secondary Outcome Timeframe: week 40 Change in lipids at week 40 12. Secondary Outcome Timeframe: week 52 Change in SBP at week 52 13. Secondary Outcome Timeframe: week 52 Change in DBP at week 52 14. Secondary Outcome Timeframe: week 52 Change in lipids at week 52 15. Safety Outcome Timeframe: week 52 the incidence of adverse events 16. Immunogenicity Outcome Timeframe: week 52 ADA and NAb Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria 1. The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender. 2. 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 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. Hypertension that was not stably controlled at screening: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg (with stable treatment for at least 30 days if antihypertensive medications were used). Have any malignant tumor within 5 years before signing ICF (except basal cell carcinoma which has received curative treatment and is regarded as cured). 5. Those who had severe infection, severe trauma, or large or medium-sized surgery within 3 months before signing ICF, or planned to undergo surgery during the study (except outpatient surgery). 6. Previous or combined presence or suspicion of depression or other psychiatric disorders or screening PHQ-9 score ≥15. 7. Known intolerance or allergy to any component of the study drug or glucagon-like peptide-1 receptor (GLP-1R) agonist, or a previous history of severe drug allergy. 8. Use of any of the following drugs, products, or treatments within 3 months prior to signing the ICF, including but not limited to: A. a drug, product or treatment with weight loss effect b. Medications, products, or treatments that significantly increase body weight 9. Use of hypoglycemic drugs within 3 months before signing ICF. 10. Have participated in any clinical trial within 3 months before signing ICF or within 5 half-lives (whichever is longer) after the last dose of the investigational drug used in the clinical trial (except for those who signed ICF without drug or device intervention). 11. History of addictive drug abuse within 1 year before signing ICF. 12. Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <60 mL/min/1.73 m2; 13. Those who donated blood or lost ≥400 mL of total blood within 3 months before signing ICF, or received blood transfusion or used blood products, or planned to donate blood during the study period. 14. Pregnant or lactating women. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Sites - Zhongshan HoapitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07521631) ## Related records ### Drugs (3) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Levodopa](https://trialight.com/data/asset/levodopa-59ec81b9-d939-4370-bed3-731916da88a8.md) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) ### Lead sponsors (1) - [Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.](https://trialight.com/data/company/hangzhou-zhongmei-huadong-pharmaceutical-co-ltd-c66360ec-49b1-40c8-8066-2d03a37a0023.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (3) - [DRD3](https://trialight.com/data/target/drd3-241e79b4-e4cd-5440-a0c1-292032211423.md) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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