Current partner codePEPTIDESDE
NCT07109700·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

216

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

HDM1005 1

administered SC, QW, 20 weeks

DRUG

HDM1005 2

administered SC, QW, 20 weeks

DRUG

HDM1005 3

administered SC, QW, 20 weeks

DRUG

HDM1005 4

administered SC, QW, 20 weeks

DRUG

Placebo

administered SC, QW, 20 weeks

DRUG

Dulaglutide 1.5 MG

administered SC, QW, 20 weeks

Timeline

From registration to results.

  1. First posted

    Aug 7, 2025

  2. Study start

    Apr 30, 2025

  3. Primary completion

    Jan 31, 2026

  4. Study completion

    Feb 28, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Aug 17, 2025

Outcomes

What the study measures.

Primary outcomes

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline, Week 20

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.

Secondary outcomes

Change from baseline in HbA1c

Time frame · Baseline, Week 12

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%

Time frame · Week 20

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Change frome baseline in fasting plasma glucose (FPG)

Time frame · Baseline, Week 12 and Week 20

FPG is a test to determine sugar levels in serum sample after an overnight fast.

Change from baseline in body weight

Time frame · Baseline, Week 12 and Week 20

Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks; * Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% * Body Mass Index (BMI within the range of 22.5 \~ 40.0 kg/m2 Exclusion Criteria: * Other types of diabetes besides T2DM * Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF) * History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF * History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2) * History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease within 24 weeks prior to signing the ICF * Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis * Use of antidiabetic medications within 12 weeks prior to signing the ICF * Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male) * FPG ≥13.9 mmol/L * Aspartate aminotransferase (AST) \>2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>2.5× ULN * Total bilirubin \>1.5× ULN * Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL)

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University People's Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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