Vibegron for Obesity

Overseen By Tina E. Brinkley, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Must not be taking: Weight loss drugs, Beta blockers

Disqualifiers: Major depression, Cognitive impairment, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults with obesity.

Research Team

Tina E Brinkley, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for middle-aged and older adults who are obese. Participants should be interested in testing whether Vibegron can help with energy metabolism, reduce heart-related risk factors, and improve physical and mental functions.

Inclusion Criteria

I am obese based on my BMI and waist size.

Exclusion Criteria

I have an irregular heartbeat or an abnormal heart test result.

Drug/substance abuse or excessive alcohol use within the past 6 months

Current participation in another intervention or research study that prohibits co-enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Vibegron or placebo daily for 12 weeks

12 weeks

Baseline, Week 4, and Week 12 visits (in-person)

Safety/Compliance

Participants' medication adherence and safety are assessed

12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vibegron

Trial Overview The study tests Vibegron against a placebo over 12 weeks to see if it improves metabolic, cardiometabolic risks, and functional abilities in aging individuals with obesity. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo.

Participant Groups

Group I: Vibegron Experimental Treatment 1 Intervention

Participants in this arm will take 75mg/day Vibegron for 12 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will take placebo daily for 12 weeks.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+