NCT06814938

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_4 obesity

Timeline
30mo left

Started Feb 2025

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2025Nov 2028

First Submitted

Initial submission to the registry

February 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

February 21, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 3, 2025

Last Update Submit

February 26, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Percentage of Responders >5%

    24 weeks

  • Percentage of Responders >10%

    24 weeks

  • Percentage of Responders >15%

    24 weeks

  • Percentage of Responders >20%

    24 weeks

  • Change in Total Body Weight at 3 months

    Baseline, 3 months

  • +2 more secondary outcomes

Study Arms (2)

Semaglutide Group

EXPERIMENTAL

Subjects will take semaglutide weekly for 24 weeks

Drug: Semaglutide

Placebo Group

PLACEBO COMPARATOR

Subjects will take placebo weekly for 24 weeks.

Drug: Placebo

Interventions

SemaglutideDRUG

2.4 mg subcutaneous weekly

Semaglutide Group
PlaceboDRUG

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

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andres Acosta, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Schaefer

CONTACT

507-266-6004Schaefer.Megan@mayo.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 7, 2025

Study Start

February 21, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)