Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity

Launched by STANFORD UNIVERSITY · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirzepatide to see if it can help people with overweight or obesity improve their health. Specifically, the researchers want to find out if tirzepatide can make fat cells healthier and help with weight loss, which may reduce the risk of diseases like type 2 diabetes and heart disease. They will compare the effects of tirzepatide to a low-calorie diet over 22 weeks in adults who are overweight or obese and have certain health risks.

To be eligible for the trial, participants must be between 18 and 70 years old, have a body mass index (BMI) between 27 and 39.9, and not have diabetes. Those who are overweight must also have at least one weight-related health issue, like high blood pressure or high cholesterol. Participants can expect to follow a specific diet and receive either the medication or dietary guidance, while the researchers will monitor their body fat, muscle health, and how well their body uses insulin. This trial is important because it could provide new insights into how to treat obesity and its related health issues in humans.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • nondiabetic as defined by fasting plasma glucose \< 126 mg/dL while off all glucose lowering medications
• • BMI 27-39.9 kg/m2. Individuals with obesity (BMI 30-39.9 kg/m2) are not required to have an additional risk factor but those who are overweight (27-29.9 kg/m2) must have at least one weight-related factor as follows: hypertension defined as physician-diagnosed and taking antihypertensive medication or SBP\> 130 or DBP \> 80 mm Hg; dyslipidemia defined as physician diagnosed and taking medication or LDL \> 160 mg/dL, TG \> 150 mg/dL, HDL \< 50 or \< 40 mg/dL for women and men, respectively; prediabetes defined as fasting glucose 100-125 mg/dL off all antidiabetic or diabetogenic medications, physician diagnosed obstructive sleep apnea, non-alcoholic fatty liver disease, history of gallstones, and osteoarthritis.
• • Age 18-70
• • Pre and postmenopausal women will be eligible and details of last menstrual period and/or hormone replacement collected for statistical adjustment and formal testing for effect modification.
• Exclusion Criteria:
• • prior bariatric surgery or liposuction
• • unstable body weight defined as self-reported weight change \>2 kg over the past 6 weeks
• • unstable hypertension (defined as BP \>160/100 mm Hg)
• • major organ disease
• • chronic inflammatory conditions
• • pregnancy/lactation
• • active malignancy undergoing treatment
• • use (current or within the past three months) of diabetogenic or weight loss medications, including GLP1 analogs
• • active eating or psychiatric disorder
• • heavy alcohol use (\>2 drinks/day for women and \> 3 drinks/day for men) will be excluded