NCT02819440

PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction

Completed Phase 2 Results posted Last updated 3 May 2022

What this trial tests

Phase 2 trial testing Tadalafil in Healthy in 141 participants. Completed in 1 June 2020.

Timeline

1 July 2016

Primary endpoint
1 June 2020

1 June 2020

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	141
Start date	1 July 2016
Primary completion	1 June 2020
Estimated completion	1 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Tadalafil (tadalafil) — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →
• Obese — all drugs for Obese →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 21 to 50, any sex, with Healthy or Obese. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day)
  Time frame: 12 weeks
  Subjects will undergo a metabolic chamber protocol to measure resting exercise energy expenditure (kcal/min) at 12 weeks adjusted statistically for the baseline measurement.
• Insulin Sensitivity After 12 Weeks of Drug Therapy
  Time frame: 12 weeks
  Subjects will undergo an insulin modified fasting intravenous glucose tolerance test (FS-IVGTT) protocol at 12 weeks adjusted statistically for the baseline measurement.

Sponsor's own description

Obesity and its adverse cardiometabolic consequences are major public health problems. Several features of obesity contribute to the associated cardiovascular risk and are potential targets for intervention. These include insulin resistance and beta cell dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic health in individuals who are obese and insulin resistant.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways in obesity: mechanisms and therapeutic interventions.
   Wen X, Zhang B, Wu B, Xiao H, et al · · 2022 · cited 245× · PMID 36031641 · DOI 10.1038/s41392-022-01149-x
2. Comprehensive Review of Current and Upcoming Anti-Obesity Drugs.
   Son JW, Kim S. · · 2020 · cited 92× · PMID 33389955 · DOI 10.4093/dmj.2020.0258