ObesityPhase 2NCT06886126
Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus
A Phase 2 study of Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to 30 Nov 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 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 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%.
- 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 2.
- 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.
- The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization:
- Unstable angina pectoris;
- cardiac insufficiency (New York Heart Association [NYHA] class III or IV);
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- Myocardial infarction;
- Coronary artery bypass grafting or percutaneous coronary intervention;
- Severe arrhythmias such as sick sinus syndrome, second or third degree atrioventricular block;
- Cerebrovascular accidents, such as cerebral infarction, transient ischemic attack, etc.
- 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).
- 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.
- Any laboratory test during the screening period met the following criteria:
- Hemoglobin <100 g/L in women and <110 g/L in men;
- alanine aminotransferase >2.5× upper limit of normal (ULN), or aspartate aminotransferase >2.5×ULN, or total bilirubin >1.5×ULN (Gilbert's syndrome subjects with direct bilirubin <ULN can participate in this study);
- TG >5.6 mmol/L;
- HbA1c ≥6.5%, or fasting plasma glucose ≥7.0 mmol/L or <3.9 mmol/L;
- Calcitonin ≥50 ng/L;
- Thyroid stimulating hormone >6 mIU/L or <0.4 mIU/L;
- serum amylase or lipase >2.0×ULN;
- Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <60 mL/min/1.73 m2;
- Positive test results for active hepatitis B, active hepatitis C, or treponema pallidum antibodies at screening; Antibodies to the human immunodeficiency virus were not negative.
- Alcohol abuse within 1 year before signing the ICF (i.e. more than 14 standard units per week for men and 7 standard units per week for women, with 1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine).
- 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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Yibing Lu
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Obese Nondiabetic Adult Subjects
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
- Obesity
- Being tested
- HDM1005 injection or placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005 injection or placeboDrug
HDM1005 injection subcutaneous injection QW for 22weeks
| Study group | Role | What they receive |
|---|---|---|
| HDM1005 dose cohort 1 QW | Experimental | Not described Receives: Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 2 QW | Experimental | Not described Receives: Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 3 QW | Experimental | Not described Receives: Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 4 QW | Experimental | Not described Receives: Drug: HDM1005 injection or placebo |
| placebo QW | Placebo comparator | Not described Receives: Drug: HDM1005 injection or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Body Weight at Week 22
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Measured: Baseline, Week 22
Secondary outcomes (8)
Percentage Change From Baseline in Body Weight at Week 4, Week 8, Week 12, Week 16
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 22
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Measured: Baseline, Week 22
Change From Baseline in Body Mass Index (BMI)
BMI was recorded in kg/m2
Measured: Baseline, Week 22
Change From Baseline in Waist Circumference
Waist Circumference was recorded in cm
Measured: Baseline, Week 22
Percentage change from baseline in fasting lipid profile (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, non HDL cholesterol, lipoprotein (a) (Lp[a]), triglycerides)
Fasting Lipid Profiles were measured at planned time points.
Measured: Baseline, Week 22
Change From Baseline in Systolic and Diastolic Blood Pressure
Blood Pressure was measured using an automated device
Measured: Baseline, Week 22
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram and Number of Participants With Treatment Emergent Adverse Events
Vital signs (blood pressure, pulse rate, body temperature, respiratory rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase)
Measured: Baseline to Week 26
Pharmacokinetic (PK) Profiles of HDM1005
Antidrug antibodies (ADA) and neutralizing antibody(NAb) profiles of HDM1005
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start7 Feb 2025
- Primary completion23 Sep 2025
- Study completion30 Nov 2025 (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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, Doctor, Principal investigator, Zhongshan Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886126
- Sponsor's protocol ID
- HDM1005-202
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Obese Nondiabetic Adult Subjects
- ClinicalTrials.gov ID
- NCT06886126
- Acronym / sponsor ID
- HDM1005-202
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HDM1005 dose cohort 1 QW | Experimental | Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 2 QW | Experimental | Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 3 QW | Experimental | Drug: HDM1005 injection or placebo |
| HDM1005 dose cohort 4 QW | Experimental | Drug: HDM1005 injection or placebo |
| placebo QW | Placebo comparator | Drug: HDM1005 injection or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. 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 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%.
- 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 (33 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 2.
- 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.
- The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization:
- 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).
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 injection or placeboHDM1005 injection subcutaneous injection QW for 22weeks | Drug | HDM1005 dose cohort 1 QW, HDM1005 dose cohort 2 QW, HDM1005 dose cohort 3 QW, HDM1005 dose cohort 4 QW, placebo QW |
Primary outcome
Percentage Change From Baseline in Body Weight at Week 22
Time frame: Baseline, Week 22
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
8 secondary outcomes
Percentage Change From Baseline in Body Weight at Week 4, Week 8, Week 12, Week 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 22
Time frame: Baseline, Week 22
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 22
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 22
Percentage change from baseline in fasting lipid profile (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, non HDL cholesterol, lipoprotein (a) (Lp[a]), triglycerides)
Time frame: Baseline, Week 22
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Baseline, Week 22
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram and Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline to Week 26
Pharmacokinetic (PK) Profiles of HDM1005
Time frame: Baseline to Week 26
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 30 Sep 2025.
- 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, Doctor principal investigator
Zhongshan Hospital, Shanghai, China
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 of 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 3 inclusion and 33 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 30 Sep 2025. 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. Some participants in this study may receive a placebo. 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 Yu Zhao (+86 16621373277, cxyzhaoyu@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Body Weight at Week 22 (time frame: Baseline, Week 22). 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 30 Sep 2025.