Current partner codePEPTIDESDE
NCT06814938·Phase 4·INTERVENTIONAL

A Study of a Novel Precision Medicine Approach For Obesity

Status

Active, not recruiting

Phase

Phase 4

Enrollment

135

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

DRUG

Semaglutide

2.4 mg subcutaneous weekly

DRUG

Placebo

Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly

Timeline

From registration to results.

  1. First posted

    Feb 7, 2025

  2. Study start

    Feb 21, 2025

  3. Primary completion

    Dec 2027

  4. Study completion

    Nov 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 16, 2026

Outcomes

What the study measures.

Primary outcomes

Change in Total Body Weight at 24 weeks

Time frame · Baseline, 24 weeks

Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.

Secondary outcomes

Percentage of Responders >5%

Time frame · 24 weeks

Percentage of participants who loss 5% of more of total body weight

Percentage of Responders >10%

Time frame · 24 weeks

Percentage of participants who loss 10% of more of total body weight

Percentage of Responders >15%

Time frame · 24 weeks

Percentage of participants who loss 15% of more of total body weight

Percentage of Responders >20%

Time frame · 24 weeks

Percentage of participants who loss 20% of more of total body weight

Change in Total Body Weight at 3 months

Time frame · Baseline, 3 months

Percent change in body weight

Change in Total Body Weight at 6 months

Time frame · Baseline, 6 months

Percent change in body weight

Change in Waist Circumference

Time frame · Baseline, 24 weeks

Reported in centimeters (CM)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.