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Not yet recruiting NCT07444073

Assessing Biological Aging in a Real-World Medical Weight Loss Program Using the LinAge2 Clinical Clock

Observational Aging Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable. This is an observational study..
Who it may be relevant to
Registry conditions: Aging, Obesity & Overweight. Basic parameters: 40 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study examines whether routine treatment with semaglutide or tirzepatide, prescribed with lifestyle coaching in a real-world weight-management program, is associated with changes in biological age measured by the LinAge2 clinical aging clock over 6 months.

Detailed description

This study will evaluate whether routine treatment with semaglutide or tirzepatide, prescribed in conjunction with lifestyle coaching support as part of standard-of-care in a real-world clinical weight-loss program, is associated with changes in biological age as measured by the LinAge2 clock. Aging is a primary driver of chronic disease, functional decline, and mortality. Obesity, through mechanisms such as mitochondrial dysfunction, oxidative stress, and chronic inflammation, may accelerate biological aging. Given that GLP-1 receptor agonists such as semaglutide and tirzepatide improve metabolic and cardiovascular health, this study will examine whether these benefits extend to biological aging as quantified by LinAge2, a clinical aging clock derived from standard clinical biomarkers.

This is a six-month prospective observational cohort study involving approximately 440 adults aged 40-89 years who are overweight or obese and newly enrolled in the weight management program at NOVI Health (T3 Health PTE LTD), a private healthcare provider in Singapore. Clinical care and program delivery are provided by NOVI Health as part of routine practice. Participants will receive standard-of-care GLP-1 RA therapy (semaglutide or tirzepatide) together with personalized diet and physical activity interventions. Study procedures include baseline and six-month visits at the NOVI Health clinic, where anthropometry, body composition, blood and urine samples, questionnaires, and functional performance assessments will be conducted. Blood and urine samples will be collected by trained and certified nurses or phlebotomists, analyzed by an accredited external laboratory, and discarded thereafter; no biological materials will be stored.

The National University of Singapore (NUS) research team provides scientific leadership in study design and conducts the development and application of the LinAge2 biological aging clock and analyses of de-identified data generated during routine clinical care at NOVI Health. NUS is not involved in participant recruitment, informed consent, clinical procedures, drug prescription, or biospecimen handling. The primary outcome is change in LinAge2 biological age from baseline to six months. Secondary outcomes include changes in body composition, cardiometabolic biomarkers, and functional clinical measures.

Interventions

  • Other Not applicable. This is an observational study.
    Not applicable. This is an observational study.

Primary outcome measures

  • LinAge2 Biological Age [Time frame: Baseline and 6 months]
Secondary outcome measures (12)
  • Change in Body Composition: Body Weight [Time frame: Baseline and 6 months]
  • Change in Body Composition: Body Mass Index (BMI) [Time frame: Baseline and 6 months]
  • Change in Body Composition: Waist Circumference [Time frame: Baseline and 6 months]
  • Change in Body Composition: Hip Circumference [Time frame: Baseline and 6 months]
  • Change in Body Composition: Waist-to-Hip Ratio [Time frame: Baseline and 6 months]
  • Change in Pulse Rate [Time frame: Baseline and 6 months]
  • Change in Blood Pressure [Time frame: Baseline and 6 months]
  • Change in Body Composition: Body Fat Percentage [Time frame: Baseline and 6 months]
  • Change in Body Composition: Muscle Mass [Time frame: Baseline and 6 months]
  • Change in Body Composition: Basal Metabolic Rate [Time frame: Baseline and 6 months]
  • Change in Body Composition: Metabolic Age [Time frame: Baseline and 6 months]
  • Change in Functional Clinical Measures: Handgrip Strength (Southampton protocol) [Time frame: Baseline and 6 months]

Eligibility criteria

Inclusion criteria

  • Adults aged 40-89 years, who are newly enrolled in the NOVI OP+ weight management program.
  • BMI of ≥ 30 kg/m2 (obesity); OR
  • BMI of ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition e.g. dysglycemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.

Exclusion criteria

  • Pregnancy or lactation.
  • Non-ambulatory status, total blindness, complete hearing loss, or inability to speak.
  • Medical history of, or self-reported, psychiatric illness, congenital or irreversible neurodegenerative diseases, cognitive impairment, or eating disorders that may affect adherence or assessment outcomes.
  • On GLP-1 RA, sulfonylurea or insulin medications for the past 3 months.
  • Active cancer on chemotherapy or immunotherapy.
  • Known hypersensitivity or contraindications to GLP-1 RAs.
  • Any condition, in the opinion of the attending clinician, that would jeopardize participant safety or interfere with study compliance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 2 centers
  • NOVI Health (T3 Health PTE LTD) — Singapore
  • National University of Singapore — Singapore

Publications

  • Fong S, Pabis K, Latumalea D, Dugersuren N, Unfried M, Tolwinski N, Kennedy B, Gruber J. Principal component-based clinical aging clocks identify signatures of healthy aging and targets for clinical intervention. Nat Aging. 2024 Aug;4(8):1137-1152. doi: 10.1038/s43587-024-00646-8. Epub 2024 Jun 19. PMID 38898237

Identifiers

NCT: NCT07444073 · NUS-IRB-2025-845

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗