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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 75

Semaglutide versus calorie restriction for adults with type 2 diabetes

Official title: 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

Run by Second Affiliated Hospital of Nanchang University · NCT07272343 · Data updated 2026-11-12

This study will test whether 12 weeks of semaglutide injections or a reduced-calorie diet better improves blood sugar, weight, liver fat, and inflammation in adults newly diagnosed with type 2 diabetes.

More Type 2 Diabetes Mellitus (T2DM) trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment100 (estimated)
SponsorSecond Affiliated Hospital of Nanchang University
Academic / other
Locations1 site (Jiangxi, Nanchang)
StatusRecruiting
StartedFebruary 10, 2023
Main results expectedJune 30, 2026
Study endsJuly 1, 2026
Registry record updatedApril 2, 2026
Trial IDNCT07272343 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18–75 years old with BMI ≥25 kg/m², newly diagnosed type 2 diabetes (≤3 months), HbA1c ≤8.5%, not currently on antihyperglycemic drugs, and willing to follow the treatment plan and attend follow-up visits.

Probably not a fit

Patients with BMI <25, longer-standing diabetes, HbA1c >8.5%, prior bariatric surgery, recent weight-loss treatment, or current use of excluded diabetes medications are different from the enrolled population and may not benefit from these findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional study compares 12 weeks of subcutaneous semaglutide injections with a concurrent energy-restricted dietary program in adults recently diagnosed with type 2 diabetes. Eligible participants are 18–75 years old with BMI ≥25 kg/m², HbA1c ≤8.5%, diabetes duration ≤3 months, and no prior antihyperglycemic medications. Key outcomes include glycemic control, weight loss, inflammatory markers, liver fat content, measures of subcutaneous and visceral fat, and exploratory molecular mechanism analyses. The single-center study is conducted at the Second Affiliated Hospital of Nanchang University with scheduled follow-up visits to monitor treatment effects.

Why it matters

Potential benefit: If successful, the results could show whether starting semaglutide early gives greater short-term improvements in blood sugar, weight, liver fat, and inflammation than calorie restriction alone.

How similar studies have gone: Large trials have shown GLP-1 receptor agonists like semaglutide and calorie restriction each improve glycemic control and weight, but direct short-term head-to-head comparisons in newly diagnosed patients are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Minde road No.1
    Jiangxi, Nanchang, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68Semaglutide 3Second Affiliated Hospital of Nanchang University 28
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.