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Phosphodiesterase Inhibitor

Tadalafil for Obesity

Phase 2
Recruiting
Led By Evan Brittain, MD, MSci
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obesity (BMI ≥ 30 kg/m2)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing whether a drug that helps blood flow can also help reduce fat storage in obese people.

Who is the study for?
This trial is for adults with obesity (BMI ≥ 30 kg/m2) who are not pregnant, breastfeeding, or planning to become pregnant. Participants should not have a history of significant heart conditions, seizures, diabetes, anemia, or use medications affecting CYP3A4 enzymes. They must weigh less than 300 pounds and not be using PDE5 inhibitors or certain blood pressure medicines.Check my eligibility
What is being tested?
The study tests the effect of Tadalafil (a drug commonly used for erectile dysfunction), on fat metabolism in obese individuals compared to a placebo. It's randomized and double-blinded meaning neither participants nor researchers know who gets the real drug. Fat metabolism is checked by MRI scans and fat tissue sampling.See study design
What are the potential side effects?
Tadalafil may cause headaches, indigestion, back pain, muscle aches, flushing, stuffy or runny nose. Rarely it can lead to priapism (prolonged erection), vision changes like NAION or hearing loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is 30 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subcutaneous adipose tissue expression of UCP1 (normalized expression units)
Thermoneutral FSF of WAT at the level of the umbilicus at 12 Weeks.
Secondary outcome measures
Cold-exposed fat signal fraction of white adipose tissue and grown adipose tissue
Subcutaneous adipose tissue gene expression of mitochondrial genes (normalized expression units)
Subcutaneous adipose tissue natriuretic peptide receptor expression
+1 more
Other outcome measures
BAT perfusion under thermoneutral and cold conditions
Change in BNP concentration during cold exposure
Change in free fatty acid level during cold exposure
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TadalafilActive Control1 Intervention
Subjects will be randomized to one of two arms. 50 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: screening visit, baseline visit, an interim visit (10 weeks post-baseline), and a 12-week visit.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be randomized to one of two arms. 50 obese adult subjects will be randomized to the placebo arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of a placebo pill (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the placebo comparator subjects will undergo the following visit protocol: screening visit, baseline, an interim visit (10 weeks post-baseline), and a 12-week visit.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,092 Total Patients Enrolled
35 Trials studying Obesity
6,781 Patients Enrolled for Obesity
Evan Brittain, MD, MSciPrincipal Investigator - VUMC
Vanderbilt University Medical Center

Media Library

Tadalafil (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04684589 — Phase 2
Obesity Research Study Groups: Tadalafil, Placebo
Obesity Clinical Trial 2023: Tadalafil Highlights & Side Effects. Trial Name: NCT04684589 — Phase 2
Tadalafil (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684589 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements for participation in this experiment?

"This trial is attempting to recruit 100 volunteers who are aged between 19 and 50 with a Body Mass Index (BMI) of 30kg/m2 or greater."

Answered by AI

Could you please detail the other research initiatives related to Tadalafil?

"At present, 15 clinical trials are being conducted for Tadalafil with 3 of those proceeding to Phase 3. Though the primary testing area is Shibīn Al Kawm in Menoufia Governorate, there are 189 other sites operating experiments involving this treatment."

Answered by AI

How many individuals are being accepted into this medical experiment?

"Affirmative. The clinicaltrial.gov database affirms that this medical trial, initially posted on March 16th 2021, is presently accepting new candidates. 100 people need to be enrolled from one site for the study to proceed as planned."

Answered by AI

What are the chief aims of this investigation?

"The purpose of this clinical trial, to be conducted over a 12 week period, is to measure the Thermoneutral FSF of WAT at the umbilicus. Secondary objectives include assessing Cold-exposed fat signal fraction in white adipose tissue and growth via MRI measurement for lipid content; additionally, gene expression levels will be measured in subcutaneous adipose tissues regarding mitochondrial genes and natriuretic peptide receptors."

Answered by AI

Is enrollment for this experiment currently accessible to participants?

"Affirmative. According to clinicaltrials.gov, this investigation is presently recruiting individuals and was first published on March 16th 2021 with a most recent update occurring in March 29th 2022. At the moment it requires 100 volunteers from one single site."

Answered by AI

Has the Federal Drug Administration granted its stamp of approval to Tadalafil?

"Tadalafil's safety was assessed to be a 2 on the scale of 1-3 due to its Phase 2 status, signifying that there is prior evidence substantiating its security but not yet any clinical data validating efficacy."

Answered by AI

Is the eligibility criteria for this investigation inclusive of individuals over 35 years old?

"Based on the parameters set forth in this clinical trial, potential participants must be between 19 and 50 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
Evan Brittain 2021. "Effect of PDE5 Inhibition on Adipose Metabolism in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684589.
All > Cialis
~27 spots leftby Jul 2025
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