Phase 1 Obesity Trial, Recruiting NCT06446531 Sponsor: The University of Texas Health Science Center at San Antonio Condition: Obesity
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Phase 1 Obesity Trial, Recruiting

NCT06446531
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 who have been diagnosed with pre-diabetes within the last 6 months, confirmed by an accepted test
  • People aged 18 years or older
  • People with a Body Mass Index (BMI) between 25 and 40 (a measure of body weight relative to height)
  • People whose HbA1c (a blood sugar average over roughly 3 months) is between 5.7% and 6.4%
  • People whose blood pressure is below 160/100
  • People whose kidneys are functioning at an acceptable level, as measured by a blood test called eGFR (confirm with trial site)
  • People whose body weight has stayed within about 5 pounds over the last 3 months
  • People who take water pills (diuretics), if applicable, and have been on a stable dose for at least 1 week before joining the trial
  • People who identify as Hispanic
  • People who are willing to follow the medication schedule for up to 6 months
  • Male or female participants; female participants must meet all of the following: not currently pregnant or breastfeeding, have a negative pregnancy test at the first visit, and women who could become pregnant must use effective contraception (such as implants, pills, or have a vasectomized partner) throughout the entire study
  • People who do not have severe claustrophobia (fear of enclosed spaces)
  • People with no medical reasons preventing them from having an MRI scan (for example, no metal plates, screws, shrapnel, pins, or a cardiac pacemaker in their body)

Who may not be able to join:

  • People who are currently taking one of the specific medications being studied in the trial (confirm with trial site)
  • People who have already been diagnosed with Type 2 Diabetes
  • Women who are pregnant, breastfeeding, or of childbearing age and unwilling to use contraception
  • People with a known allergy or sensitivity to the study medications or their ingredients
  • People who have had a major cancer diagnosis within the last 5 years
  • People with current drug or alcohol use that, in the investigator's opinion, could affect their ability to follow the study requirements
  • People, or their legal guardians, who are unable or unwilling to provide written consent to participate
  • People with serious organ, metabolic, or physical conditions that would prevent them from completing the study
  • People who have had a heart attack, heart bypass surgery, or another major heart event in the past 60 days
  • People who have received a heart transplant or are on a waiting list for one
  • People who currently have a mechanical heart-assist device implanted
  • People with certain types of heart muscle disease or a condition causing the sac around the heart to be abnormally stiff (confirm with trial site)
  • People with severe disease affecting the heart valves that is expected to require surgery during the trial
  • People who have had a serious episode of heart failure requiring hospital-level treatments such as intravenous medications or mechanical support within 1 week before or during the screening period
  • People who have had a heart device (implanted cardioverter defibrillator) fitted within the 3 months before screening
  • People who have a cardiac resynchronization therapy device (a type of pacemaker used for heart failure)

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 12 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: Carolina Solis-Herrera, MD, The University of Texas Health Science Center at San Antonio

Phone: 210-567-4900

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
The University of Texas Health Science Center at San Antonio
Registry
ClinicalTrials.gov
Start date
11 September 2024
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hemoglobin A1c Level (HBA1c)

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: 12 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