DelfaGLP-1 Atlas

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RecruitingPhase 3

A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

Asset

Efpeglenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

118

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c ≤10%

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 IDNCT07379333
Org study IDHM-GLOW-301

Timeline

Milestones

Study first posted2026-01-30actual
Study start2026-04-13actual
Last update posted2026-05-13actual
Primary completion2027-11estimated (month precision)
Study completion2028-01estimated (month precision)

Assets

Investigational agents

Efpeglenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•1. Adults aged 19 years or older
•2. Diagnosed with type 2 diabetes
•3. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%
•4. Stable administration of metformin (≥1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1
•5. 20 kg/m2 ≤ BMI ≤ 45 kg/m2
•6. Agree to the recommended exercise and diet regimen during this clinical trial

Exclusion criteria

•1. Patients with a history of allergy or resistance to the investigational drug or background therapy
•2. Patients diagnosed with a type of diabetes other than type 2 diabetes
•3. Patients with uncontrolled severe diabetic complications
•4. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.
•5. Patients with a history of diabetic coma or precoma
•6. Those with a history of severe hypoglycemia
•7. Those whose weight change > 5 kg
•8. History of gastrointestinal disease or surgery
•9. History of bariatric surgery
•10. History of gallbladder disease
•11. History of a disease that could affect the interpretation of HbA1c
•12. History of acute or chronic pancreatitis or pancreatectomy
•13. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2).
•14. Uncontrolled hypertension
•15. Severe infections or severe trauma
•16. Malnutrition, starvation, or debility, as determined by the investigator.
•17. Pituitary or adrenal insufficiency.
•18. Tissue hypoxia, such as respiratory failure or shock.
•19. History of alcoholism or drug abuse
•20. History of malignant tumors
•21. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA
•22. Patients with one of the following clinical laboratory test results : Amylase or Lipase > 3 X ULN / FPG > 270 mg/dL
•23. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT > 3 X ULN / Total bilirubin > 1.5 X ULN
•24. Patients with moderate or severe renal impairment
•25. History of Diabetic medications or weight-loss medications
•26. Those who have participated in another clinical trial and received investigational drugs within 30 days
•27. Pregnant or lactating women, or women of childbearing potential
•28. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods
•29. Considered by investigator as not appropriate to participate in the clinical study with other reason.

Endpoints (6)

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.

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Change in HbA1c at 36 weeks compared to baseline

Time frame:baseline, 36 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in HbA1c at Week 24

Time frame:baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36

Time frame:24, 36 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36

Time frame:24, 36 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in FPG at Weeks 24 and 36

Time frame:baseline, 24, 36 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Proportion of subjects receiving rescue medication at Weeks 24 and 36

Time frame:24, 36 weeks

threshold achievement, event

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.