A Study of a Novel Precision Medicine Approach for Obesity

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Semaglutide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06814938

1R44DK138619 (U.S. NIH Grant/Contract)

23-006754

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 2 patient groups, including a placebo group

Semaglutide Group

Experimental group

Description:

Subjects will take semaglutide weekly for 24 weeks

Treatment:

Drug: Semaglutide

Placebo Group

Placebo Comparator group

Description:

Subjects will take placebo weekly for 24 weeks.

Treatment:

Drug: Placebo