30 Participants NeededMy employer runs this trial

Tirzepatide for Obesity in Young Adult Cancer Survivors

EK
Overseen ByEfstratios Koutroumpakis, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: GLP-1/GIP receptor agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Tirzepatide for young adult cancer survivors dealing with obesity. It focuses on individuals who have survived soft tissue or bone cancer and completed chemotherapy approximately three months ago. Participants should be overweight or obese and have at least one heart-related risk factor, but not require medication for diabetes. The goal is to determine if Tirzepatide can aid in weight management and improve health outcomes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Is there any evidence suggesting that Tirzepatide is likely to be safe for humans?

An earlier study found tirzepatide to be generally well-tolerated by participants. Most experienced only mild side effects, such as nausea, diarrhea, and reduced appetite. These effects were usually temporary and improved over time. Importantly, the FDA has already approved tirzepatide for treating type 2 diabetes, indicating its safety is well-understood. However, as this trial is in its early stages, monitoring for any new side effects specific to this group of participants remains crucial.12345

Why do researchers think this study treatment might be promising?

Tirzepatide is unique because it targets obesity by mimicking two hormones, GIP and GLP-1, which play a key role in regulating blood sugar and appetite. Unlike current obesity treatments that often focus solely on appetite suppression or calorie absorption, tirzepatide offers a dual mechanism that can enhance weight loss and improve metabolic health. Researchers are excited about this treatment because it is administered as a convenient once-weekly injection and has shown potential in other studies to provide significant weight loss and improvements in related metabolic conditions.

What evidence suggests that Tirzepatide might be an effective treatment for obesity in young adult cancer survivors?

Research has shown that tirzepatide, the treatment under study in this trial, aids weight loss in people with obesity. In various studies, participants taking tirzepatide lost significant weight, often between 15% to 25% of their starting weight. Specifically, one study found that participants lost up to 21.3% of their body weight in 72 weeks. This weight loss typically exceeds that achieved by other treatments. Tirzepatide mimics hormones that regulate appetite, helping people eat less and lose weight. Overall, evidence suggests tirzepatide can be a strong option for weight loss.678910

Who Is on the Research Team?

EK

Efstratios Koutroumpakis, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for young adults (ages 18-39) who survived soft tissue or bone sarcoma, are overweight or obese, finished a certain amount of chemotherapy about three months ago, and have normal heart function.

Inclusion Criteria

My heart is working well with no or mild symptoms of heart failure.
Overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²) at enrollment
Women of childbearing potential must agree to use adequate contraception beginning at enrollment and continuing for duration of Tirz therapy
See 7 more

Exclusion Criteria

I have recovered from side effects of previous cancer treatments, except for hair loss.
I have had pancreatitis, medullary thyroid cancer, or MEN2 syndrome.
Pregnancy or breastfeeding
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tirzepatide as a once-weekly subcutaneous injection for up to 1 year

1 year
6 visits (in-person) over the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study tests tirzepatide, a medication given to help prevent heart problems linked to obesity in cancer survivors. All participants receive the drug; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Phase II: Treatment with TirzepatideExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

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