Using tirzepatide to improve metabolic health in people with obesity or overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of tirzepatide, a dual GLP/GIP agonist, on metabolic health in individuals with overweight or obesity. Participants will undergo a week of weight maintenance followed by baseline metabolic testing, including insulin resistance assessments and imaging scans. After baseline evaluations, participants will receive tirzepatide or dietary interventions, with aggressive weight loss strategies implemented initially. The study will monitor changes in metabolic health, fat distribution, and adipose tissue function over a 22-week period.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical and Translational Research Unit
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Tracey McLaughlin, MD — Stanford School of Medicine
• Study coordinator: Nicole Turk, BS
• Email: nturk@stanford.edu
• Phone: 6508880144

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.