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

Last updated: March 14, 2025
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Treatment

HDM1005 injection or placebo

Clinical Study ID

NCT06886126
HDM1005-202
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The age of signing ICF was from 18 to 65 years old (including both ends), regardlessof 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

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, ormultiple endocrine neoplasia type 2.

  3. According to the investigator's judgment, the subjects have endocrine diseases orhistories that affect gastric emptying, may significantly affect body weight, ordiseases or conditions that affect the absorption of gastrointestinal nutrients,such as Cushing syndrome, hypothyroidism or hyperthyroidism, bariatric surgery orother gastrectomy, irritable bowel syndrome, dyspepsia, and chronic pancreatitis; Ora history of acute pancreatitis or acute gallbladder disease within 3 months beforesigning ICF.

  4. The following cardiovascular and cerebrovascular diseases or conditions occurredwithin 6 months before randomization:

  5. Unstable angina pectoris;

  6. cardiac insufficiency (New York Heart Association [NYHA] class III or IV);

  7. Myocardial infarction;

  8. Coronary artery bypass grafting or percutaneous coronary intervention;

  9. Severe arrhythmias such as sick sinus syndrome, second or third degreeatrioventricular block;

  10. Cerebrovascular accidents, such as cerebral infarction, transient ischemicattack, etc.

  11. 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).

  12. Have any malignant tumor within 5 years before signing ICF (except basal cellcarcinoma which has received curative treatment and is regarded as cured).

  13. Those who had severe infection, severe trauma, or large or medium-sized surgerywithin 3 months before signing ICF, or planned to undergo surgery during the study (except outpatient surgery).

  14. Previous or combined presence or suspicion of depression or other psychiatricdisorders or screening PHQ-9 score ≥15.

  15. Known intolerance or allergy to any component of the study drug or glucagon-likepeptide-1 receptor (GLP-1R) agonist, or a previous history of severe drug allergy.

  16. Use of any of the following drugs, products, or treatments within 3 months prior tosigning the ICF, including but not limited to: A. a drug, product or treatment with weight loss effect b. Medications, products, ortreatments that significantly increase body weight

  17. Use of hypoglycemic drugs within 3 months before signing ICF.

  18. 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 drugused in the clinical trial (except for those who signed ICF without drug or deviceintervention).

  19. History of addictive drug abuse within 1 year before signing ICF.

  20. Any laboratory test during the screening period met the following criteria:

  21. Hemoglobin <100 g/L in women and <110 g/L in men;

  22. alanine aminotransferase >2.5× upper limit of normal (ULN), or aspartateaminotransferase >2.5×ULN, or total bilirubin >1.5×ULN (Gilbert's syndromesubjects with direct bilirubin

  23. TG >5.6 mmol/L;

  24. HbA1c ≥6.5%, or fasting plasma glucose ≥7.0 mmol/L or <3.9 mmol/L;

  25. Calcitonin ≥50 ng/L;

  26. Thyroid stimulating hormone >6 mIU/L or <0.4 mIU/L;

  27. serum amylase or lipase >2.0×ULN;

  28. Estimated glomerular filtration rate (eGFR) according to the Chronic KidneyDisease Epidemiology Collaboration (CKD-EPI) equation <60 mL/min/1.73 m2;

  29. Positive test results for active hepatitis B, active hepatitis C, or treponemapallidum antibodies at screening; Antibodies to the human immunodeficiencyvirus were not negative.

  30. Alcohol abuse within 1 year before signing the ICF (i.e. more than 14 standard unitsper week for men and 7 standard units per week for women, with 1 standard unitcontaining 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mLof wine).

  31. Those who donated blood or lost ≥400 mL of total blood within 3 months beforesigning ICF, or received blood transfusion or used blood products, or planned todonate blood during the study period.

  32. Pregnant or lactating women.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: HDM1005 injection or placebo
Phase: 2
Study Start date:
February 07, 2025
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing,
    China

    Active - Recruiting

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