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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus

Phase II Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Obese Nondiabetic Adult Subjects

Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus (NCT06886126) is a Phase 2 interventional studying Obesity, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Obesity and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Obesity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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%. (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. Who Should NOT Join This Trial: 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 2. 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. The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization: 1. Unstable angina pectoris; 2. cardiac insufficiency (New York Heart Association \[NYHA\] class III or IV); 3. Myocardial infarction; 4. Coronary artery bypass grafting or percutaneous coronary intervention; 5. Severe arrhythmias such as sick sinus syndrome, second or third degree atrioventricular block; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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%. (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 2. 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. The following cardiovascular and cerebrovascular diseases or conditions occurred within 6 months before randomization: 1. Unstable angina pectoris; 2. cardiac insufficiency (New York Heart Association \[NYHA\] class III or IV); 3. Myocardial infarction; 4. Coronary artery bypass grafting or percutaneous coronary intervention; 5. Severe arrhythmias such as sick sinus syndrome, second or third degree atrioventricular block; 6. Cerebrovascular accidents, such as cerebral infarction, transient ischemic attack, etc. 5. 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). 6. Have any malignant tumor within 5 years before signing ICF (except basal cell carcinoma which has received curative treatment and is regarded as cured). 7. 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). 8. Previous or combined presence or suspicion of depression or other psychiatric disorders or screening PHQ-9 score ≥15. 9. 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. 10. 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 11. Use of hypoglycemic drugs within 3 months before signing ICF. 12. 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). 13. History of addictive drug abuse within 1 year before signing ICF. 14. Any laboratory test during the screening period met the following criteria: 1. Hemoglobin \<100 g/L in women and \<110 g/L in men; 2. 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); 3. TG \>5.6 mmol/L; 4. HbA1c ≥6.5%, or fasting plasma glucose ≥7.0 mmol/L or \<3.9 mmol/L; 5. Calcitonin ≥50 ng/L; 6. Thyroid stimulating hormone \>6 mIU/L or \<0.4 mIU/L; 7. serum amylase or lipase \>2.0×ULN; 8. Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<60 mL/min/1.73 m2; 9. 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. 15. 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). 16. 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. 17. Pregnant or lactating women.

Treatments Being Tested

DRUG

HDM1005 injection or placebo

HDM1005 injection subcutaneous injection QW for 22weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06886126), the sponsor (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06886126 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06886126?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06886126?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06886126. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06886126. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.