A Study of a Novel Precision Medicine Approach For Obesity

A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Megan Schaefer; Phone Number: 507-266-6004; Email: Schaefer.Megan@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide Group; Subjects will take semaglutide weekly for 24 weeks	Drug: Semaglutide; 2.4 mg subcutaneous weekly
Placebo Comparator: Placebo Group; Subjects will take placebo weekly for 24 weeks.	Drug: Placebo; Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); Phenomix Sciences
• Investigators: Principal Investigator: Andres Acosta, MD, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: 23-006754; 1R44DK138619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No