Clinical trial NCT06814938: A Study of a Novel Precision Medicine Approach for Obesity
Official title: A Novel Precision Medicine Approach for Obesity: a Randomized, Multi-Center Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Phenomix Sciences
First posted: 2025-02-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Body Weight at 24 weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Percentage of Responders >5%
timeFrame: 24 weeks
measure: Percentage of Responders >10%
timeFrame: 24 weeks
measure: Percentage of Responders >15%
timeFrame: 24 weeks
measure: Percentage of Responders >20%
timeFrame: 24 weeks
measure: Change in Total Body Weight at 3 months
timeFrame: Baseline, 3 months
measure: Change in Total Body Weight at 6 months
timeFrame: Baseline, 6 months
measure: Change in Waist Circumference
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andres Acosta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: