Phase 1 Obesity Trial, Recruiting NCT02646475 Sponsor: Vanderbilt University Condition: Obesity
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Phase 1 Obesity Trial, Recruiting

NCT02646475
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 60 years of any race or gender
  • People with obesity, defined as a body mass index (BMI) between 30 and 40 kg/m²
  • People with insulin resistance, measured by a specific blood test score (called HOMA2-IR) greater than 2.2
  • People with high blood pressure, either shown by two or more seated blood pressure readings above 130/85 mmHg, or by currently taking blood pressure-lowering medication
  • People who are able and willing to give their informed consent to participate

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People who currently smoke or have a history of heavy smoking (more than 2 packs per day)
  • People with a history of alcohol or drug abuse
  • People with severe obesity (BMI above 40 kg/m²)
  • People who have previously had an allergic reaction to the medications used in this study
  • People with type 1 or type 2 diabetes, including those with a fasting blood sugar above 126 mg/dl or those taking diabetes medications
  • People with heart conditions other than high blood pressure, such as a heart attack within the past 6 months, chest pain (angina), serious irregular heartbeat, heart failure, blood clots in the legs or lungs, certain heart rhythm or valve problems, or a thickened heart muscle
  • People with a history of serious brain or blood vessel conditions, such as a brain bleed, stroke, or mini-stroke (TIA)
  • People with a history or current diagnosis of immune system or blood disorders
  • People with poor liver function, based on specific blood test results
  • People with poor kidney function, based on a blood test showing creatinine levels above 1.5 mg/dl
  • People with anaemia (low haemoglobin levels — below 13.5 g/dl in males or below 12.5 g/dl in females)
  • People currently being treated with a class of antidepressants called SNRIs, or medications that affect a protein called the norepinephrine transporter (NET) (confirm with trial site)
  • People currently taking medications known as phosphodiesterase 5 inhibitors (used for conditions such as erectile dysfunction or pulmonary hypertension)
  • People currently taking blood-thinning (anticoagulant) medications
  • People who have taken steroid medications (glucocorticoids) for more than 7 days in a row within a single month
  • People who have taken part in another clinical drug trial within the month before this study
  • People who are unable to give or withdraw their informed consent
  • People who, in the opinion of the trial investigators, have other health or personal factors that would prevent them from completing the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alfredo Gamboa, MD, Vanderbilt University Medical Center

Phone: 615-421-1994

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Vanderbilt University
Registry
ClinicalTrials.gov
Start date
1 February 2016
Est. completion
1 December 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Whole-Body Insulin Sensitivity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov