60 Participants NeededMy employer runs this trial

Gemtesa for Cardiovascular Function in Aging Women

JL
Overseen ByJacqueline Limberg Associate Professor
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Gemtesa can improve blood vessel function in aging women by targeting specific receptors (beta3 adrenergic receptors) in their blood vessels. The study involves two main activities: participants place their foot in ice water, and an ultrasound checks blood flow in the arm. The trial seeks healthy women with a body mass index (BMI) below 18 or above 30, who do not have conditions like diabetes or high blood pressure. As an Early Phase 1 trial, this research aims to understand how Gemtesa works in people, offering participants a unique opportunity to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy or have certain health conditions like cardiovascular disease, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Gemtesa (vibegron) is generally safe and well tolerated. For older adults using Gemtesa for overactive bladder (OAB), research found that the rate of high blood pressure matched that of those taking a placebo, which contains no active medicine. Another study showed no significant effect on blood pressure compared to a placebo. Available data indicate no major safety concerns about Gemtesa related to heart health.

While Gemtesa is approved for treating overactive bladder, this trial tests it for a different use. Although this research is in the early stages, the existing safety data for its approved use is reassuring.12345

Why are researchers excited about this trial?

Researchers are excited about Gemtesa for improving cardiovascular function in aging women because it offers a novel approach. Unlike current treatments that primarily focus on managing cardiovascular symptoms through lifestyle changes or medications like statins and beta-blockers, Gemtesa is being explored for its potential benefits beyond its known use for bladder issues. This trial is investigating its unique effects on cardiovascular responses, like how blood vessels react to stress and improve blood flow, which could provide new insights and options for women as they age.

What evidence suggests that Gemtesa might be an effective treatment for cardiovascular function in aging women?

Research has shown that Gemtesa, a medication for overactive bladder, might also benefit heart health in older women. Gemtesa relaxes muscles and may enhance energy use while reducing heart-related risks in older adults. Studies have demonstrated that Gemtesa is safe and effective for older adults, with similar outcomes in both older and younger individuals. The medication could potentially widen blood vessels, improving blood flow and heart function. Although primarily used for bladder issues, it might also support heart health. Participants in this trial will undergo either the Cold Pressor Test or Flow Mediated Dilation to assess cardiovascular function.12678

Are You a Good Fit for This Trial?

This trial is for older women, likely those who are postmenopausal. Participants should be generally healthy aside from age-related changes and must not have conditions or take medications that could interfere with the study.

Inclusion Criteria

Body mass index less than 18 or greater than or equal to 30 kg/m2
I am between 18 and 70 years old.
I am a healthy woman assigned female at birth.

Exclusion Criteria

Breastfeeding
Pregnancy
Hypersensitivity to nitroglycerin
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cold Pressor Test

Participants will be exposed to the cold pressor test (ice water on the foot)

1 day
1 visit (in-person)

Flow Mediated Dilation

Participants will be exposed to the high-resolution ultrasound following inflation of a cuff around the forearm

1 day
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

  • Gemtesa

Trial Overview

The study compares Gemtesa (a medication) to a placebo to see if targeting beta3-adrenergic receptors can improve blood vessel function in aging women. Participants are randomly assigned to receive either Gemtesa or a placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Flow Mediated DilationExperimental Treatment2 Interventions
Group II: Cold pressor testExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Citations

Established safety of GEMTESA for older adults at 12 weeks

No overall differences in safety or effectiveness of GEMTESA. Incidence of cardiovascular-associated AEs,* including hypertension (1.3%) and increased blood ...

Efficacy of GEMTESA® (vibegron) 75 mg tablets in Older ...

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ years and younger adult patients

An Evaluation of the Efficacy and Safety of Vibegron in ... - PMC

These studies showed that vibegron works well, is safe, and may be able to help patients who have overactive bladder manage their symptoms better.

Vibegron for ENergy Thinking and Resilience in Aging

Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults ...

Results of GEMTESA® Clinical Studies

At 12 weeks, people taking GEMTESA and those taking placebo had similar rates of hypertension (1.7% vs 1.7%, respectively), and increased blood pressure (0.7% ...

Safety of GEMTESA® (vibegron) 75 mg tablets in OAB

* In a 12-week pivotal study, hypertension rates for OAB patients taking GEMTESA (n=545) were 1.7% vs 1.7% with placebo (n=540). Increased BP rates were 0.7% ...

Gemtesa - accessdata.fda.gov

There are no available data on GEMTESA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or ...

OAB in Older Adults | GEMTESA® (vibegron) 75 mg tablets

With proven efficacy and an established safety profile for older adults, GEMTESA can help reduce the impact of urinary urgency, leakage episodes, and frequency.