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RecruitingPhase 4

The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

A Study on the Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes Combined With Metabolic-associated Fatty Liver Disease and Its Molecular Mechanisms

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

100

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Eligibility highlights

BMI ≥25HbA1c ≤8.5%

Primary endpoints

HbA1c, changeFasting glucose, changePostprandial glucose

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07272343
Org study ID2022efyA04

Timeline

Milestones

Study start2023-02-10actual
Study first posted2025-12-09actual
Last update posted2026-04-02actual
Primary completion2026-06-30estimated
Study completion2026-07-01estimated

Assets

Investigational agents

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age 18-75 years;

2. BMI≥25 kg/m²;

3. Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";

4. HbA1c≤8.5%;

5. Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;

6. Willing to participate in this study, and after full informed consent, agrees to strictly follow the treatment plan and promises to attend follow-up visits on time, and signs the informed consent form.

Exclusion criteria

1. BMI < 25 kg/m²;

2. Age < 18 years, or > 75 years;

3. History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;

4. History of bariatric surgery or planned bariatric surgery, or currently attempting weight loss within the past 3 months, or use of weight-loss medications within the past 3 months;

5. Use of GLP-1 receptor agonists, sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, or other related drugs within the past 3 months;

6. Pregnant or breastfeeding women, or those planning to conceive during the study period;

7. Patients with severe diseases of important organ systems, such as severe cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, renal insufficiency, hematologic diseases, neurological diseases, or malignancies;

8. Personal or family history of medullary thyroid carcinoma;

9. Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.

Endpoints (8)

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
Cardiometabolic biomarkers
4

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

HbA1c

Time frame:From enrollment to the end of treatment at 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

FPG

Time frame:From enrollment to the end of treatment at 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

2hPG

Time frame:From enrollment to the end of treatment at 12 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

HOMA-IR

Time frame:From enrollment to the end of treatment at 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

TC

Time frame:From enrollment to the end of treatment at 12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

TG

Time frame:From enrollment to the end of treatment at 12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

LDL-C

Time frame:From enrollment to the end of treatment at 12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

HDL-C

Time frame:From enrollment to the end of treatment at 12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.