DelfaGLP-1 Atlas

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MESSAGE

RecruitingPhase 4

Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control

Efficacy and Safety of the Triple Combination Therapy of Met/SGLT-2i/GLP-1RA or Other Oral Antidiabetic Drugs in Patients With Type 2 Diabetes Exhibiting Poor Glycemic Control

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

430

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7.5-11%

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 IDNCT07244003
Org study IDHD-LLPHYJ-LC-1

Timeline

Milestones

Study start2025-03-29actual
Study first posted2025-11-24actual
Last update posted2025-11-24actual
Primary completion2027-12-31estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female;
•Body mass index (BMI) ≥20kg/m² ;
•Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C >=7.5% and<=11.0%);
•Volunteer to participate in this study and sign informed consent.

Exclusion criteria

•Patients with type 1 diabetes or other special types of diabetes;
•Patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening
•Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy
•Those who received insulin treatment within the previous week
•Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides > 5.7 mmol/L during the screening period
•Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 UNL, or total blood bilirubin (TBIL) > 2 UNL;
•Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL/min/1.73m² or serum creatinine≥1.5 UNL;
•Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2)
•Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period
•Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs;
•Those who have participated in other drug clinical trials within 3 months before screening; 21. Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.

Endpoints (12)

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

Weight & body composition
4
Glycemic / diabetes
4
Cardiometabolic biomarkers
2
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

The changes of waist circumference and hip circumference compared to the baseline

Time frame:from baseline to week 24

Waist circumference, change

change from baseline, improvement

componentsWaist circumference, change, hip circumference change

Secondary/protocol endpoint

The changes of body mass compared to the baseline

Time frame:from baseline to 24 week

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The changes of BMI compared to the baseline

Time frame:from baseline to 24 week

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

The changes of waist-hip ratio, waist-to-height ratio compared to the baseline

Time frame:from baseline to 24 week

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

The change of HbA1c compared to the baseline

Time frame:from baseline to week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets

Time frame:week 24

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Systolic BP, change, Diastolic BP, change, LDL-C, change

LOINC 4548-4

Secondary/protocol endpoint

The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning

Time frame:week 24

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

The changes of fasting blood glucose, 2-hour post-meal blood glucose, fasting glucagon, fasting insulin, insulin resistance index (HOMA-IR) compared to the baseline

Time frame:from baseline to week 24

change from baseline, improvement

componentsFasting glucose, change, Postprandial glucose, HOMA-IR (insulin sensitivity)

Renal / kidney

1 endpoint
Secondary/protocol endpoint

The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline

Time frame:from baseline to week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Changes in systolic and diastolic blood pressure compared to the baseline

Time frame:from baseline to week 24

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Other/protocol endpoint

The changes in total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, and aspartate aminotransferase compared to the baseline

Time frame:from baseline to week 120

change from baseline, improvement

componentsTotal cholesterol, change, Triglycerides, change, HDL-C, change, LDL-C, change, ALT, change, AST, change

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

The proportion of participants who received rescue treatment

Time frame:from baseline to week 24

threshold achievement, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.