A Study of a Novel Precision Medicine Approach for Obesity

Phase 4

Recruiting

• Conditions: Obesity
• Interventions: Drug: Semaglutide; Drug: Placebo

• Registration Number: NCT06814938
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.

Detailed Description

The purpose of this study is to test the effectiveness of semaglutide 2.4 mg SQ weekly in patients with obesity with a positive MyPhenome test for abnormal postprandial satiety compared to patients with obesity with a negative MyPhenome test for abnormal postprandial satiety.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Study Start: 2025-02-21
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-12
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).

Exclusion Criteria

• Weight changes greater than 3% in the previous 3 months
• History of bariatric surgery including lap band and bariatric endoscopy
• Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
• Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
• Any contraindication to FDA-approved GLP1R agonists
• A person who is pregnant or wanting to become pregnant
• Once the positive or negative cohort is filled at 2:1 ratio, some patients will be screen failed if their gene cohort is full.
• A family member who is enrolled in this study.
• Principal Investigator Discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide Group	Semaglutide	Subjects will take semaglutide weekly for 24 weeks
Placebo Group	Placebo	Subjects will take placebo weekly for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Total Body Weight at 24 weeks	Baseline, 24 weeks	Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders >5%	24 weeks	Percentage of participants who loss 5% of more of total body weight
Percentage of Responders >10%	24 weeks	Percentage of participants who loss 10% of more of total body weight
Percentage of Responders >15%	24 weeks	Percentage of participants who loss 15% of more of total body weight
Percentage of Responders >20%	24 weeks	Percentage of participants who loss 20% of more of total body weight
Change in Total Body Weight at 3 months	Baseline, 3 months	Percent change in body weight
Change in Total Body Weight at 6 months	Baseline, 6 months	Percent change in body weight
Change in Waist Circumference	Baseline, 24 weeks	Reported in centimeters (CM)

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States