Using tirzepatide to improve metabolic health in people with obesity or overweight
Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity
This study is testing if tirzepatide can help people with obesity or being overweight improve their metabolic health and lose weight over 22 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05912621 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are nondiabetic adults aged 18-70 with a BMI between 27-39.9 kg/m2 and at least one weight-related health issue.
Not a fit: Patients who are diabetic or have a BMI below 27 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved metabolic health and weight management for patients with obesity or overweight.
How similar studies have performed: Other studies have shown promising results with GLP/GIP agonists, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.