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

NCT06886126 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HDM1005-202
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Body Weight at Week 22

  Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg

  Baseline, Week 22

Secondary Outcomes (8)

• Percentage Change From Baseline in Body Weight at Week 4, Week 8, Week 12, Week 16

  Baseline, Week 4, Week 8, Week 12, Week 16

• Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 22

  Baseline, Week 22

• Change From Baseline in Body Mass Index (BMI)

  Baseline, Week 22

• Change From Baseline in Waist Circumference

  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)

  Baseline, Week 22

Study Arms (5)

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

Interventions

HDM1005 injection or placebo DRUG

HDM1005 injection subcutaneous injection QW for 22weeks

HDM1005 dose cohort 1 QW; HDM1005 dose cohort 2 QW; HDM1005 dose cohort 3 QW; HDM1005 dose cohort 4 QW; placebo QW

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li, Doctor

  Zhongshan Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhao

CONTACT

+86 16621373277; cxyzhaoyu@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 20, 2025
• Study Start: February 7, 2025
• Primary Completion: September 23, 2025
• Study Completion: November 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)