Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

NCT07193459 | Recruiting Phase 3 FDA Drug

• 1 other identifier: HDM1002-302
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only

Conditions

Type 2 Diabetes

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 40

  Week 40

Secondary Outcomes (12)

• Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia

  Week 40

• Change from baseline in body weight, body mass index (BMI), and waist circumference

  Weeks 40

• Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%

  Weeks 40

• Change From Baseline in Fasting plasma Glucose, fasting C-peptide and fasting insulin

  Weeks 40

• Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)

  Weeks 40

Study Arms (3)

HDM1002 200mg

EXPERIMENTAL

Participants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD

Drug: HDM1002 200 mg

HDM1002 400mg

EXPERIMENTAL

Participants received maintenance dose 400 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD

Drug: HDM1002 400 mg

Placebo

PLACEBO COMPARATOR

Participants received placebo orally QD

Drug: Placebo

Interventions

HDM1002 200 mg DRUG

HDM1002 tablets, 200 mg once daily

HDM1002 200mg

HDM1002 400 mg DRUG

HDM1002 tablets, 400 mg once daily

HDM1002 400mg

Placebo DRUG

Placebo tablets, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 75 years of age (inclusive).
• Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF.
• HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.
• Having a body mass index (BMI) of 22.5 to 40.0 kg/m2, inclusive.
• Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration.
• Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.

You may not qualify if:

• Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus
• Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing ICF.
• Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)
• History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)
• Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.
• Have had any of the following within 3 months prior to screening:
• Unstable angina；
• Heart failure (New York Heart Association, class III or IV);
• Myocardial infarction (MI)；
• Coronary artery bypass grafting or percutaneous coronary intervention；
• Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.)；
• Cerebrovascular accident
• Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study.
• Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.
• Those who have used the following drugs within 14 days before randomization or within 5 half-lives (whichever is longer), or who need to use the following drugs for a long time during the trial, are excluded: strong or moderate inhibitors of cytochrome P450 enzyme (CYP) 3A4, strong inducers of CYP3A4, strong inhibitors of P-gp, strong inducers of P-gp, inhibitors of OATP1B1 or OATP1B3, or narrow therapeutic index drugs that are CYP2C8, CYP3A4, UGT1A1, P-gp, OATP1B1 or OATP1B3 substrates.

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 25, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)