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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Vibegron, also known as GEMTESA, can improve metabolism and overall health in individuals with obesity. Participants will take either Vibegron or a placebo (a sugar pill) daily for 12 weeks to determine its effects on energy levels, heart health, and physical and mental function. The study seeks individuals living with obesity, specifically those with a BMI of 30 or higher, or a BMI of 27 or higher with a large waist. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a promising treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as weight loss drugs, medications or supplements that change energy metabolism, adrenergic agonists, beta blockers, and antimuscarinic medications for overactive bladder.

Is there any evidence suggesting that Vibegron is likely to be safe for humans?

Research has shown that vibegron is generally safe for humans. Studies have found that vibegron effectively and safely manages symptoms in people with an overactive bladder. At a dose of 50 mg per day for 12 weeks, it was well-tolerated and led to significant symptom improvement.

Safety checks identified few serious risks associated with vibegron treatment. Some unwanted effects were noted, but they were not considered a major concern. Real-world studies also suggest that patients continue using vibegron, indicating it is manageable in daily life.

Since vibegron is in a Phase 3 trial for obesity, earlier phases have already tested its safety. This phase typically means the treatment has been shown to be safe in smaller groups and is now being tested in larger groups to confirm those findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity that often involve lifestyle changes, medications like phentermine or orlistat, and sometimes surgery, Vibegron offers a new approach. Researchers are excited about Vibegron because it targets the beta-3 adrenergic receptors, which are involved in energy expenditure and fat breakdown. This unique mechanism of action could potentially lead to weight loss by increasing metabolism and reducing fat storage, offering an alternative for those who struggle with traditional weight management strategies.

What evidence suggests that Vibegron might be an effective treatment for obesity?

Research has shown that vibegron effectively treats overactive bladder (OAB) and is generally safe. In these studies, taking 50 mg of vibegron daily for 12 weeks improved symptoms. In the current trial, participants will receive either 75 mg/day of vibegron or a placebo for 12 weeks to evaluate its potential for weight loss. Although vibegron is being tested for this purpose, no direct proof yet supports its effectiveness for weight loss. Researchers hope vibegron might boost metabolism and lower heart-related health risks, but this remains under investigation. The effectiveness of vibegron for weight loss will depend on the results of this ongoing research. ^{1 2 4 6 7}

Who Is on the Research Team?

Tina E Brinkley, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8901416/

An Evaluation of the Efficacy and Safety of Vibegron ... Across all studies, vibegron was efficacious, safe, and well tolerated and thus represents a valuable treatment option for patients with OAB.

2. withpower.com withpower.com/trial/vibegron-for-obesity-0c30c

Vibegron for Obesity · Info for Participants Trial Overview The study tests Vibegron against a placebo over 12 weeks to see if it improves metabolic, cardiometabolic risks, and functional abilities in ...

3. ctv.veeva.com ctv.veeva.com/study/vibegron-a-novel-treatment-for-multisystem-functional-decline-in-aging-and-obesity

Vibegron - A Novel Treatment for Multisystem Functional ... This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/luts.12529

Efficacy and safety of Vibegron for the treatment of residual ... The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in ...

5. link.springer.com link.springer.com/article/10.1007/s12325-024-02824-x

Real-World Adherence to and Persistence with Vibegron in ... This analysis assessed real-world adherence and persistence with vibegron in patients with OAB, along with demographics and clinical characteristics associated ...

6. ema.europa.eu ema.europa.eu/en/documents/rmp-summary/obgemsa-epar-risk-management-plan_en.pdf

Obgemsa , INN-vibegron - European Medicines Agency ... safety results identified few clinically relevant risks associated with vibegron therapy. Additionally, ADRs identified from post-marketing.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01500382

NCT01500382 | A Study of the Pharmacokinetics and ... The primary safety hypothesis is that administration of multiple oral doses of vibegron is sufficiently well-tolerated in participants with overactive bladder, ...