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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

Must not have

Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study

History of diabetes mellitus or use of anti-diabetic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

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.

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.

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

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My BMI is 30 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and willing to prevent pregnancy during the study.

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I have diabetes or take medication for it.

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I am currently taking medication for high blood pressure.

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I am either younger than 19 or older than 50.

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I have gone through menopause.

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I have a history of heart issues or seizures.

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I am not taking medications that strongly affect liver enzyme levels.

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I have been diagnosed with non-arteritic ischemic optic neuropathy.

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I am currently taking medication for erectile dysfunction.

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I have been diagnosed with HIV.

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I am currently using organic nitrates.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subcutaneous adipose tissue expression of UCP1 (normalized expression units)

Thermoneutral FSF of WAT at the level of the umbilicus at 12 Weeks.

Secondary study objectives

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 study objectives

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.

0 / 12Eligibility criteria met