Adults With Simple ObesityNCT07293325
Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity
A study testing Semaglutide, Tirzepatide and Metformin in people with Adults With Simple Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adults With Simple Obesity
- What is being tested?
- Semaglutide, Tirzepatide and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2025to 2 Jun 2027
- Phase
- Interventional
- 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
- Adults aged 18 to 75 years.
- Diagnosed with simple obesity, defined as BMI ≥ 30 kg/m².
- Have not used any anti-obesity medications (including GLP-1 RAs, tirzepatide, metformin for weight loss, etc.) within the past 3 months.
- Able and willing to comply with study procedures and complete follow-up assessments.
- Provide written informed consent.
Who cannot join
- Presence of secondary obesity (e.g., endocrine disorders such as Cushing's syndrome or hypothyroidism).
- Use of anti-obesity medications or participation in another weight-loss program within the past 3 months.
- Diagnosed type 1 or type 2 diabetes mellitus requiring hypoglycemic drug therapy.
- History of pancreatitis, severe gastrointestinal disease, or bariatric surgery.
- Severe cardiovascular, hepatic, renal, or psychiatric disease that may affect participation.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- Current participation in any other clinical trial.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Chao Zheng, 18857116176, chao_zheng@zju.edu.cn
About this study
Official title: Assessing the Role of GLP-1 Receptor Agonist Semaglutide and Dual GLP-I/GIP Receptor Agonist Tirzepatide in Delaying Genetic Aging in Adult Obese Patients Using the iWatchAge Technology
This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Changes in "biological (epigenetic) age" will be assessed using the iWatchAge DNA methylation age test, while simultaneously monitoring improvements in aging-related biomarkers such as inflammatory factors, metabolic parameters, and body composition. The aim is to determine whether incretin-based therapies can reverse or slow obesity-related accelerated epigenetic aging and to provide new clinical evidence for interventions targeting obesity and aging.
- Conditions
- Adults With Simple Obesity
- Being tested
- Semaglutide, Tirzepatide, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide administered once weekly by subcutaneous injection.Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks
TirzepatideDrug
Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks
MetforminDrug
Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Group | Experimental | Semaglutide administered once weekly by subcutaneous iniection. Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks Receives: Drug: Semaglutide |
| Tirzepatide Group | Experimental | Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks Receives: Drug: Tirzepatide |
| Metformin Group | Active comparator | Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DNA methylation-based biological age measured by iWatchAge
Change in epigenetic biological age from baseline to Week 24, measured using the iWatchAge DNA methylation assay. This outcome reflects whether semaglutide, tirzepatide, or metformin can delay or reverse obesity-associated accelerated epigenetic aging.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start2 Jun 2025
- Primary completion2 Apr 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Simple ObesityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293325
- Sponsor's protocol ID
- 2025-0568
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of GLP-1 Receptor Agonist Semaglutide and Dual GLP-I/GIP Receptor Agonist Tirzepatide in Delaying Genetic Aging in Adult Obese Patients Using the iWatchAge Technology
- ClinicalTrials.gov ID
- NCT07293325
- Acronym / sponsor ID
- 2025-0568
- Conditions
- Adults With Simple Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 19 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.
This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Changes in "biological (epigenetic) age" will be assessed using the iWatchAge DNA methylation age test, while simultaneously monitoring improvements in aging-related biomarkers such as inflammatory factors, metabolic parameters, and body composition. The aim is to determine whether incretin-based therapies can reverse or slow obesity-related accelerated epigenetic aging and to provide new clinical evidence for interventions targeting obesity and aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | Experimental | Drug: SemaglutideSemaglutide administered once weekly by subcutaneous iniection. Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks |
| Tirzepatide Group | Experimental | Drug: TirzepatideTirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks |
| Metformin Group | Active comparator | Drug: MetforminMetformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years.
- Diagnosed with simple obesity, defined as BMI ≥ 30 kg/m².
- Have not used any anti-obesity medications (including GLP-1 RAs, tirzepatide, metformin for weight loss, etc.) within the past 3 months.
- Able and willing to comply with study procedures and complete follow-up assessments.
- Provide written informed consent.
Key exclusion criteria (8 listed)
- Presence of secondary obesity (e.g., endocrine disorders such as Cushing's syndrome or hypothyroidism).
- Use of anti-obesity medications or participation in another weight-loss program within the past 3 months.
- Diagnosed type 1 or type 2 diabetes mellitus requiring hypoglycemic drug therapy.
- History of pancreatitis, severe gastrointestinal disease, or bariatric surgery.
- Severe cardiovascular, hepatic, renal, or psychiatric disease that may affect participation.
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 |
|---|---|---|
| SemaglutideSemaglutide administered once weekly by subcutaneous injection.Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks | Drug | Semaglutide Group |
| TirzepatideTirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks | Drug | Tirzepatide Group |
| MetforminMetformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks | Drug | Metformin Group |
Primary outcome
Change in DNA methylation-based biological age measured by iWatchAge
Time frame: Baseline and Week 24
Change in epigenetic biological age from baseline to Week 24, measured using the iWatchAge DNA methylation assay. This outcome reflects whether semaglutide, tirzepatide, or metformin can delay or reverse obesity-associated accelerated epigenetic aging.
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 19 Dec 2025.
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 study testing Semaglutide, Tirzepatide and Metformin in people with Adults With Simple Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 8 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 19 Dec 2025. 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.
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 Chao Zheng (18857116176, chao_zheng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA methylation-based biological age measured by iWatchAge (time frame: Baseline and Week 24). 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 19 Dec 2025.