DelfaGLP-1 Atlas

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RecruitingPhase 2

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

A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet/Exercise or Metformin Therapy

Assets

Dulaglutide / HDM1005

Listed sites

1

Recruiting sites

1

Enrollment

216

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07109700
Org study IDHDM1005-201

Timeline

Milestones

Study start2025-04-30actual
Study first posted2025-08-07actual
Last update posted2025-08-17actual
Primary completion2026-01-31estimated
Study completion2026-02-28estimated

Assets

Investigational agents

DulaglutideHDM1005

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline, Week 12 and Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 20

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in HbA1c

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 20

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, HbA1c <7.0% achievement

LOINC 4548-4

Secondary/protocol endpoint

Change frome baseline in fasting plasma glucose (FPG)

Time frame:Baseline, Week 12 and Week 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.