Phase 4 Type 2 Diabetes Trial, Recruiting NCT05708859 Sponsor: Matthew J. Budoff Condition: Type 2 Diabetes
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Phase 4 Type 2 Diabetes Trial, Recruiting

NCT05708859
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:

  • People aged between 40 and 80 years old at the time of signing the consent form
  • People who have had Type 2 diabetes for at least 5 years, with blood sugar levels (HbA1c) between 7.0% and 10.5%
  • People with a Body Mass Index (BMI) of 25 or higher (considered overweight or obese)
  • People who have two specific fatty buildups in their heart arteries, detected by a special heart scan (CT scan of the coronary arteries), where each buildup causes more than 20% narrowing of the artery
  • People who have been on a stable diabetes medication regimen for more than 4 weeks before the start of the trial
  • People taking hormonal contraceptive pills must switch to a non-pill contraceptive method, or add a barrier method (such as condoms), for 4 weeks after starting the trial medication and for 4 weeks after each dose increase

Who may not be able to join:

  • People who have had a major heart or cardiovascular event in the last 60 days
  • People who have Type 1 diabetes
  • People who are currently using a medication class known as GLP-1 receptor agonists (such as medications like semaglutide or liraglutide)
  • People who have had a serious low blood sugar episode, or who cannot feel the warning signs of low blood sugar, within the last 6 months
  • People who are currently receiving or planning treatment for diabetic eye disease (retinopathy) or fluid buildup in the eye (macular edema)
  • People who have previously had, or are currently planning, a procedure to open or bypass blocked arteries in the heart, neck, or legs (such as a stent or bypass surgery)
  • People with a history of pancreas inflammation (pancreatitis)
  • People with a history of a dangerous diabetes-related condition involving very high blood sugar with acid buildup (ketoacidosis) or an extremely high blood sugar emergency (hyperosmolar state or coma)
  • People who have a known problem with their stomach emptying too slowly, or who have had or are planning surgery on the stomach outlet or any form of weight-loss (bariatric) stomach surgery
  • People who currently have cancer, have had cancer in the past that is considered significant, or have been in remission from a significant cancer for less than 5 years
  • People who have a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related inherited condition (Multiple Endocrine Neoplasia type 2)
  • People who have had a blood transfusion or significant blood loss within the past 90 days, or who have a known blood condition that could affect the accuracy of HbA1c blood sugar tests
  • People who have had or are planning heart bypass surgery
  • People for whom the heart CT scan (CCTA) is not safe or suitable — for example, due to a serious allergy to the contrast dye used — or whose scan did not meet the required quality standards after two attempts
  • People with severely uncontrolled high blood pressure (above 180/100 mmHg) at the screening visit, even while on blood pressure medication
  • People with advanced heart failure (classified as NYHA Class III or IV) at the screening visit
  • People with significantly reduced kidney function (eGFR below 40 ml/min/1.73m²) as measured at the screening visit
  • People who have been hospitalised for a major heart event, including heart failure, in the past 2 months

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 27 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: Matthew A Budoff, MD, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Phone: 13109749336

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
Sponsor
Matthew J. Budoff
Registry
ClinicalTrials.gov
Start date
2 January 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Reduction of total non-calcified coronary plaque volume

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: 27 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