ObesityPhase 2NCT07521631
Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes
A Phase 2 study testing HDM1005 dose level 1, HDM1005 dose level 2 and HDM1005 dose level 3 in people with Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- HDM1005 dose level 1, HDM1005 dose level 2 and HDM1005 dose level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 23 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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%.
- 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.
Who cannot join
- Previous diagnosis of type 1, type 2, or any other type of diabetes.
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type
- 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.
- 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).
- 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).
Show all 16Show fewer
- Previous or combined presence or suspicion of depression or other psychiatric disorders or screening PHQ-9 score ≥15.
- 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.
- Use of any of the following drugs, products, or treatments within 3 months prior to signing the ICF, including but not limited to:
- a drug, product or treatment with weight loss effect b. Medications, products, or treatments that significantly increase body weight
- Use of hypoglycemic drugs within 3 months before signing ICF.
- 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).
- History of addictive drug abuse within 1 year before signing ICF.
- Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <60 mL/min/1.73 m2;
- 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.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hoapital
Shanghai
Xiaoying Li, +86 021-64041990, Xiaoying_li@Hotmail.com
About this study
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
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
- Obesity
- Being tested
- HDM1005 dose level 1, HDM1005 dose level 2, HDM1005 dose level 3, Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005 dose level 1Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 1, the intervention will last for 52 weeks in total.
HDM1005 dose level 2Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 2, the intervention will last for 52 weeks in total.
HDM1005 dose level 3Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 3, the intervention will last for 52 weeks in total.
TirzepatideDrug
Initiate at a once weekly dose of 2.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| HDM1005 injection dose group 1 | Experimental | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. Receives: Drug: HDM1005 dose level 1 |
| HDM1005 injection dose group 2 | Experimental | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. Receives: Drug: HDM1005 dose level 2 |
| HDM1005 injection dose group 3 | Experimental | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. Receives: Drug: HDM1005 dose level 3 |
| tirzepatide injection | Active comparator | Initiate at a once weekly dose of 2.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The percentage change in body weight from baseline to week 40
Measured: week 40
Secondary outcomes (16)
Secondary Outcome
The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 40
Measured: week 40
Secondary Outcome
The percentage change in body weight from baseline to week 52
Measured: week 52
Secondary Outcome
Change in waist circumference at week 40
Measured: week 40
Secondary Outcome
Change in body weight at week 40
Measured: week 40
Secondary Outcome
Change in BMI at week 40
Measured: week 40
Secondary Outcome
Change in BMI at week 52
Measured: week 52
Secondary Outcome
Change in waist circumference at week 52
Measured: week 52
Secondary Outcome
Change in waist body weight at week 52
Measured: week 52
Secondary Outcome
Change in systolic blood pressure (SBP) at week 40
Measured: week 40
Secondary Outcome
Change in diastolic blood pressure (DBP) at week 40
Measured: week 40
Secondary Outcome
Change in lipids at week 40
Measured: week 40
Secondary Outcome
Change in SBP at week 52
Measured: week 52
Secondary Outcome
Change in DBP at week 52
Measured: week 52
Secondary Outcome
Change in lipids at week 52
Measured: week 52
Safety Outcome
the incidence of adverse events
Measured: week 52
Immunogenicity Outcome
ADA and NAb
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Mar 2026
- Primary completion4 Feb 2027 (estimated)
- Study completion23 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, Medical doctor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521631
- Sponsor's protocol ID
- HDM1005-203
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07521631
- Acronym / sponsor ID
- HDM1005-203
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 4 Feb 2027 (estimated)
- Study completion
- 23 Jul 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HDM1005 injection dose group 1 | Experimental | Drug: HDM1005 dose level 1Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. |
| HDM1005 injection dose group 2 | Experimental | Drug: HDM1005 dose level 2Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. |
| HDM1005 injection dose group 3 | Experimental | Drug: HDM1005 dose level 3Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. |
| tirzepatide injection | Active comparator | Drug: TirzepatideInitiate at a once weekly dose of 2.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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%.
- 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.
Key exclusion criteria (16 listed)
- Previous diagnosis of type 1, type 2, or any other type of diabetes.
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM1005 dose level 1Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 1, the intervention will last for 52 weeks in total. | Drug | HDM1005 injection dose group 1 |
| HDM1005 dose level 2Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 2, the intervention will last for 52 weeks in total. | Drug | HDM1005 injection dose group 2 |
| HDM1005 dose level 3Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose level 3, the intervention will last for 52 weeks in total. | Drug | HDM1005 injection dose group 3 |
| TirzepatideInitiate at a once weekly dose of 2.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. | Drug | tirzepatide injection |
Primary outcome
Primary Outcome
Time frame: week 40
The percentage change in body weight from baseline to week 40
16 secondary outcomes
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 40
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 52
Secondary Outcome
Time frame: week 52
Safety Outcome
Time frame: week 52
Immunogenicity Outcome
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoying Li, Medical doctor principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDM1005 dose level 1, HDM1005 dose level 2 and HDM1005 dose level 3 in people with Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Tao (+86 021-64041990, cxytaoling@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.