Precision Obesity Medicine: Genetic Prediction of Response to GLP-1/GIP Agonists.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

Obesity is a chronic multifactorial disease with a strong genetic component. Although glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonists, such as tirzepatide, are highly effective treatments for obesity, substantial inter-individual variability in weight loss response remains. Genetic factors may contribute to these differences in treatment outcomes.

The aim of this prospective cohort study is to investigate whether a Genetic Risk Score (GRS) and selected obesity-related single nucleotide polymorphisms (SNPs) can predict weight loss response to semaglutide or tirzepatide in adults with obesity. Participants initiating treatment with either medication will undergo clinical, biochemical, and genetic assessment at baseline and will be followed for six months. The study will evaluate the association between genetic markers and treatment response and develop predictive models integrating genetic and clinical variables. The findings may contribute to the development of personalized treatment strategies for obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

BMI ≥40 kg/m² or ≥37 kg/m² with comorbidities

Initiation of semaglutide or tirzepatide

Disqualifiers

Prior bariatric surgery

Secondary causes of obesity

Active malignancy

Chronic pancreatitis

Trial population

Adults with obesity receiving semaglutide or tirzepatide as part of routine clinical care. Participants will undergo clinical, biochemical, and genetic assessment and will be followed prospectively for six months to evaluate the association between genetic risk score, obesity-related genetic variants, and weight loss response.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Semaglutide or Tirzepatide

    Drug

    Adults with obesity initiating treatment with semaglutide or tirzepatide as part of routine clinical care. Participants are followed prospectively for 6 months to evaluate weight loss response and its association with genetic risk score.

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: Semaglutide or Tirzepatide1 intervention

Trial outcomes

Primary outcomes

1

Percentage weight loss at 6 months

Percentage change in body weight from baseline to 6 months following treatment with semaglutide or tirzepatide. The association between weight loss response and genetic risk score (GRS) as well as obesity-related single nucleotide polymorphisms (SNPs) will be evaluated.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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National and Kapodistrian University of Athens

Lead sponsor

Laikο General Hospital, Athens

Sponsor institution