Type 2 Diabetes Mellitus (T2DM)Phase 4NCT07272343
The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes
A Phase 4 study testing semaglutide and caloric restriction in people with Type 2 Diabetes Mellitus (T2DM) and Semaglutide, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Semaglutide, Caloric Restriction
- What is being tested?
- semaglutide and caloric restriction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2023to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years;
- BMI≥25 kg/m²;
- Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";
- HbA1c≤8.5%;
- Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;
- 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.
Who cannot join
- BMI < 25 kg/m²;
- Age < 18 years, or > 75 years;
- History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;
- 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;
- 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;
- Pregnant or breastfeeding women, or those planning to conceive during the study period;
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- 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;
- Personal or family history of medullary thyroid carcinoma;
- Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Minde road No.1
Jiangxi, Nanchang, 330000
Jianping Liu, +8679186274551, ndefy14105@ncu.edu.cn
ndefy14105@ncu.edu.cn
About this study
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
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.
- Being tested
- semaglutide, caloric restriction
- Keywords
- Type 2 Diabetes Mellitus, semaglutide, Caloric Restriction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
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).
caloric restrictionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| semaglutide group | Experimental | 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). Receives: Drug: semaglutide |
| caloric restriction group | Active comparator | 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). Receives: Behavioral: caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
glycated hemoglobin
Measured: From enrollment to the end of treatment at 12 weeks
FPG
fasting plasma glucose
Measured: From enrollment to the end of treatment at 12 weeks
2hPG
2-hour postprandial glucose
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
HOMA-IR
homeostasis model assessment of insulin resistance
Measured: From enrollment to the end of treatment at 12 weeks
TC
total cholesterol
Measured: From enrollment to the end of treatment at 12 weeks
TG
triglycerides
Measured: From enrollment to the end of treatment at 12 weeks
LDL-C
low-density lipoprotein
Measured: From enrollment to the end of treatment at 12 weeks
HDL-C
high-density lipoprotein
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start10 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272343
- Sponsor's protocol ID
- 2022efyA04
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some of the data involves patient privacy. If there is a need to share the data, please contact the relevant researchers of this project.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07272343
- Acronym / sponsor ID
- 2022efyA04
- Keywords
- Type 2 Diabetes Mellitus, semaglutide, Caloric Restriction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semaglutide group | Experimental | Drug: semaglutideThe 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). |
| caloric restriction group | Active comparator | Behavioral: caloric restrictionThe caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years;
- BMI≥25 kg/m²;
- Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";
- HbA1c≤8.5%;
- Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;
Key exclusion criteria (9 listed)
- BMI < 25 kg/m²;
- Age < 18 years, or > 75 years;
- History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideThe 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). | Drug | semaglutide group |
| caloric restrictionThe caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females). | Behavioural | caloric restriction group |
Primary outcome
HbA1c
Time frame: From enrollment to the end of treatment at 12 weeks
glycated hemoglobin
FPG
Time frame: From enrollment to the end of treatment at 12 weeks
fasting plasma glucose
2hPG
Time frame: From enrollment to the end of treatment at 12 weeks
2-hour postprandial glucose
5 secondary outcomes
HOMA-IR
Time frame: From enrollment to the end of treatment at 12 weeks
TC
Time frame: From enrollment to the end of treatment at 12 weeks
TG
Time frame: From enrollment to the end of treatment at 12 weeks
LDL-C
Time frame: From enrollment to the end of treatment at 12 weeks
HDL-C
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. Some of the data involves patient privacy. If there is a need to share the data, please contact the relevant researchers of this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing semaglutide and caloric restriction in people with Type 2 Diabetes Mellitus (T2DM) and Semaglutide, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianping Liu (+8679186274551, ndefy14105@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.