Recruiting PHASE2 Obesity Prevention

New treatment option for Obesity Prevention

Official title Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

ClinicalTrials.gov ID: NCT06811324

What this study is testing

What is Tirzepatide?

Tirzepatide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity prevention.

Also referred to as Zepbound, LY3298176.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 and older

You may be able to join if

  • Men and postmenopausal women aged 50 years or older.
  • Body Mass Index (BMI) ≥30 kg/m².
  • Untreated HbA1c \<6.5% at baseline.
  • Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
  • Able to provide informed consent and participate in all study assessments.

You likely can't join if

  • Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
  • Body Mass Index (BMI) ≥ 40 kg/m².
  • Moderate to severe gastroesophageal reflux disease based on patient history.
  • Inability to comply with the treatment protocol or to understand the consent form.
  • Chronic Kidney Disease (CKD) Stage 4.
  • Aspartate aminotransferase (AST) \> 33 U/L or alanine aminotransferase (ALT) \> 36 U/L.
See the full eligibility criteria
Who can join
  • Men and postmenopausal women aged 50 years or older.
  • Body Mass Index (BMI) ≥30 kg/m².
  • Untreated HbA1c \<6.5% at baseline.
  • Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
  • Able to provide informed consent and participate in all study assessments.
What rules you out
  • Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
  • Body Mass Index (BMI) ≥ 40 kg/m².
  • Moderate to severe gastroesophageal reflux disease based on patient history.
  • Inability to comply with the treatment protocol or to understand the consent form.
  • Chronic Kidney Disease (CKD) Stage 4.
  • Aspartate aminotransferase (AST) \> 33 U/L or alanine aminotransferase (ALT) \> 36 U/L.
  • Active pregnancy.
  • Personal or family history of medullary thyroid carcinoma.
  • Personal or family history of multiple endocrine neoplasia type 2 syndrome.
  • Personal history of gastroparesis.
  • Personal history of diabetic retinopathy.
  • Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.
  • Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.
  • Concomitant treatment with GLP-1 receptor agonist therapy

The study team makes the final eligibility decision.

Where it's taking place

  • San Antonio, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.