Phase 4 Obesity Trial, Recruiting NCT06264882 Sponsor: University of Colorado, Denver Condition: Obesity
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Phase 4 Obesity Trial, Recruiting

NCT06264882
Recruiting Phase 4

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:

  • Women between the ages of 20 and 45 years old
  • Women who have regular menstrual cycles, meaning no more than one missed period in the past year
  • Women who are not currently pregnant and are not planning to become pregnant
  • Women who have not been breastfeeding in the last 3 months
  • Women with a specific hormone level (FSH below 10 IU/L), measured by a blood test in the first 10 days of their menstrual cycle, to confirm they are not approaching menopause (confirm with trial site)
  • Women who have not used hormonal contraception (such as the pill, patch, or hormonal IUD) in the last 3 months
  • Women who are either not regularly exercising or who exercise vigorously no more than 2 days per week
  • Women who are not taking medications that affect blood vessels, such as blood pressure medication, cholesterol-lowering drugs, or blood thinners
  • Women who are not taking antioxidant supplements or regular anti-inflammatory painkillers (such as ibuprofen), or who are willing to stop taking them for at least 4 weeks before the study begins

Who may not be able to join:

  • People with diabetes or a fasting blood sugar level above 126 mg/dL
  • People with a Body Mass Index (BMI) above 35 kg/m² (a measure of body weight relative to height)
  • People whose weight has changed by more than 5 kg (about 11 pounds) in the last 3 months
  • People who have used steroid medications — including inhaled, oral, or topical forms — or drugs that affect how the body processes steroids, in the last 3 months
  • People who drink more than 14 alcoholic drinks per week
  • People with a known allergy or sensitivity to the study medications
  • People with significant depressive symptoms, as measured by a standard questionnaire score above 16 (confirm with trial site)
  • People with a resting blood pressure above 150/90 mmHg
  • People with a current or past history of heart, kidney, or liver disease
  • People with an active or ongoing infection
  • People with thyroid problems, indicated by a thyroid hormone level (TSH) outside the range of 0.5 to 5.0 mU/L — though those with abnormal results may be reconsidered after follow-up with their own doctor
  • People who have smoked or used tobacco products within the past 12 months
  • People with severely low bone density or osteoporosis, indicated by a bone density T-score below -2.0 at the hip or lower spine
  • People with a history of blood clots in the veins (such as deep vein thrombosis or pulmonary embolism)
  • People with a history of breast cancer or any other cancer that is affected by oestrogen

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 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Kerrie Moreau, PhD, University of Colorado Denver Anschutz Medical Campus

Phone: 303-724-1914

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 4
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
31 May 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Brachial artery flow mediated dilation (FMD)

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: 22 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