Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-08-17

216

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet/exercise or metformin therapy. A total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5/1.0/2.0/3.0mg), there will be \~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration. The study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.

CONDITIONS

Official Title

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of Type 2 Diabetes Mellitus for at least 24 weeks
  • Hemoglobin A1c between 7.5% and 10.5%
  • Body Mass Index between 22.5 and 40.0 kg/m2
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Diagnosis of any diabetes type other than Type 2 Diabetes Mellitus
  • Acute diabetic complications within 24 weeks before consent (e.g., ketoacidosis, lactic acidosis, hyperosmolar coma)
  • History of severe or asymptomatic low blood sugar episodes within 24 weeks before consent
  • Personal or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2
  • History or risk factors for pancreatitis or symptomatic gallbladder disease within 24 weeks before consent
  • Conditions affecting stomach emptying or nutrient absorption (e.g., gastric surgery, irritable bowel syndrome, gastroparesis)
  • Use of antidiabetic drugs other than metformin within 12 weeks before consent
  • Hemoglobin levels below 100 g/L (female) or 110 g/L (male)
  • Fasting plasma glucose above 13.9 mmol/L
  • Elevated liver enzymes (AST or ALT above 2.5 times upper normal limit)
  • Total bilirubin above 1.5 times upper normal limit
  • Fasting triglycerides above 5.6 mmol/L (500 mg/dL)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

Loading map...

Research Team

L

Lepeng Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here