Effect of Tirzepatide on Brown Adipose Tissue in Obesity (NCT06893211) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effect of Tirzepatide on Brown Adipose Tissue in Obesity
Slovenia35 participantsStarted 2025-03-18
Plain-language summary
This study is testing whether a new anti-obesity medicine called tirzepatide can increase the activity of special fat cells in the body that help burn energy. These fat cells are known as brown and beige fat. The study includes women with obesity and will last 24 weeks.
Participants will receive either tirzepatide or a placebo (a look-alike injection with no active drug). Researchers will measure the amount and activity of brown fat using medical imaging (PET/CT, MRI, and thermal camera), and examine fat tissue samples to look for changes in gene activity and structure that show beige fat activation.
The study will also evaluate how these fat changes affect body weight, energy use, hormone levels, blood sugar, and other health markers. The goal is to learn whether tirzepatide helps improve metabolism by increasing energy-burning fat in addition to reducing appetite.
Who can participate
Age range
20 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female sex
* Age between 18 and 50 years
* BMI between 30 kg/m² and 40 kg/m² at pre-screening
* Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%
* Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)
* No prior pharmacological or surgical interventions for obesity
* Euthyroid state
* Eumenorrhea or Oligomenorrhea
* Ability to comprehend the study objectives and procedures
* Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate
* Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment
Exclusion Criteria:
* Pregnancy or lactation
* Postmenopausal
* Amenorea
* Type 2 diabetes
* Reliance on natural contraception methods
* Non-compliance with previous therapeutic regimens
* Personal history of malignancy
* Personal or family history of medullary thyroid carcinoma
* Personal history of pancreatitis
* Personal history of cholelithiasis
* Personal history of major depressive episodes or suicidal ideation
* Personal history of acute coronary events or hemodynamically significant coronary artery disease
* Psychiatric disorders…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Brown Adipose Tissue Activity and Volume
Timeframe: Baseline to Week 24
2
Change in Molecular Markers of Browning in Subcutaneous White Adipose Tissue