Actively Recruiting
A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-02-09
240
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled , phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus placebo in subjects with T2DM inadequate glycemic control with diet and exercise alone. A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) , then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (placebo), with 80 subjects in each treatment group. At week 36, subjects in placebo group will receive HDM1005 injection until week 52. All treatment groups will implement dose titration to achieve the target dose. The study consists of: up to 2-week screening, 2-week run-in, 36-week core treatment, 16-week extension treatment, and 4-week follow-up, totaling 60 weeks. 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 Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes for at least 12 weeks and no use of antihyperglycemic medications for at least 12 weeks before screening
- Hemoglobin A1c between 7.5% and 10.5% at screening and between 7.0% and 10.5% at randomization
- Body Mass Index (BMI) of 22.5 kg/m2 or higher
You will not qualify if you...
- Having any type of diabetes other than type 2 diabetes
- Experiencing acute diabetes complications within 24 weeks before consent
- 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 recent symptomatic gallbladder disease
- Conditions affecting stomach emptying or nutrient absorption, including certain surgeries or digestive disorders
- Use of any antidiabetic drugs within 12 weeks before consent, except short-term insulin use of 7 days or less
- Hemoglobin below 100 g/L for females or below 110 g/L for males
- Fasting plasma glucose of 13.9 mmol/L or higher
- Liver enzyme levels (AST or ALT) greater than three times the upper limit of normal
- Total bilirubin greater than 1.5 times the upper limit of normal
- Fasting triglycerides greater than 5.6 mmol/L (500 mg/dL)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wenyan Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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