Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity

NCT ID: NCT07293325

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Adults With Simple Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semaglutide Group

Semaglutide administered once weekly by subcutaneous iniection. Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Semaglutide administered once weekly by subcutaneous injection.Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks

Tirzepatide Group

Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks

Metformin Group

Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks

Interventions

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Semaglutide

Semaglutide administered once weekly by subcutaneous injection.Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks

Intervention Type DRUG

Tirzepatide

Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks

Intervention Type DRUG

Metformin

Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 to 75 years.
2. Diagnosed with simple obesity, defined as BMI ≥ 30 kg/m².
3. Have not used any anti-obesity medications (including GLP-1 RAs, tirzepatide, metformin for weight loss, etc.) within the past 3 months.
4. Able and willing to comply with study procedures and complete follow-up assessments.
5. Provide written informed consent.

Exclusion Criteria

1. Presence of secondary obesity (e.g., endocrine disorders such as Cushing's syndrome or hypothyroidism).
2. Use of anti-obesity medications or participation in another weight-loss program within the past 3 months.
3. Diagnosed type 1 or type 2 diabetes mellitus requiring hypoglycemic drug therapy.
4. History of pancreatitis, severe gastrointestinal disease, or bariatric surgery.
5. Severe cardiovascular, hepatic, renal, or psychiatric disease that may affect participation.
6. Pregnant or breastfeeding women, or women planning pregnancy during the study period.
7. Current participation in any other clinical trial.
8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chao Zheng

Role: CONTACT

Phone: 18857116176

Email: [email protected]

Facility Contacts

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Chao Zheng

Role: primary

Other Identifiers

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2025-0568

Identifier Type: -

Identifier Source: org_study_id