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NCT04684589 · ClinicalTrials.gov registry record · Phase 2

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

A Phase 2 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 2
Development phase
89
Enrollment target

NCT04684589: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.

NCT04684589 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04684589, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
89 participants
Enrollment target

Study Summary

This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5 inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount of adipose to measure gene expression.

Primary Outcome

Measured by fat signal fraction (FSF) at Week 12. FSF is the percent of MRI signal derived from lipids within a voxel. Lower FSF values indicate greater lipid consumption and correspond to brown adipose tissue (BAT), whereas higher FSF values indicate lipid storage and correspond to white adipose tissue (WAT).

Interventions

  • DRUG Placebo
  • DRUG Tadalafil 20 MG

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2021-03-16
Est. Completion 2025-06-24
Phase Phase 2

What the finished NCT04684589 record still lists

NCT04684589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04684589 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04684589 about?

NCT04684589 is a clinical study titled "Effect of PDE5 Inhibition on Adipose Metabolism in Humans". This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5 inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount of adipose to measure gene express...

What is the current status of trial NCT04684589?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2021-03-16. Estimated completion is 2025-06-24.

What interventions are being tested in trial NCT04684589?

The interventions under investigation include: Placebo (DRUG), Tadalafil 20 MG (DRUG).

Who is sponsoring clinical trial NCT04684589?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04684589's enrollment target sits among peer trials

89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04684589, the US trial registry maintained by the National Library of Medicine. NCT04684589 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.