NCT07293325

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

Study Start

First participant enrolled

June 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2027

Last Updated

December 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

November 24, 2025

Last Update Submit

December 18, 2025

Conditions

Adults With Simple Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week 24

Study Arms (3)

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

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

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.

Drug: Metformin

Interventions

SemaglutideDRUG

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

Semaglutide Group
TirzepatideDRUG

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

Tirzepatide Group
MetforminDRUG

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

Metformin Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

MeSH Terms

Interventions

semaglutideTirzepatideMetformin

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, PeptideBiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Chao Zheng

CONTACT

18857116176chao_zheng@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 19, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

April 2, 2027

Study Completion (Estimated)

June 2, 2027

Last Updated

December 19, 2025

Record last verified: 2025-06

Locations

CN(1)