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

The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes (NCT07272343) is a Phase 4 interventional studying Type 2 Diabetes Mellitus (T2DM) and Semaglutide, sponsored by Second Affiliated Hospital of Nanchang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Type 2 Diabetes Mellitus (T2DM) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form, agrees to strictly follow the treatment plan and promises to attend follow-up visits on time, and signs the willing to sign a consent form form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

semaglutide

The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12).

BEHAVIORAL

caloric restriction

The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Minde road No.1

Jiangxi, Nanchang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07272343), the sponsor (Second Affiliated Hospital of Nanchang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07272343 clinical trial studying?

Who can participate in NCT07272343?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07272343?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07272343. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07272343. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.