Status:
ACTIVE_NOT_RECRUITING
Effect of Tirzepatide on Brown Adipose Tissue in Obesity
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Obesity
Eligibility:
FEMALE
20-50 years
Phase:
PHASE2
Brief 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 be...
Eligibility Criteria
Inclusion
- 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
- 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
- Current treatment with sympathomimetics or sympatholytics
- Excessive alcohol consumption
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06893211
Start Date
March 18 2025
End Date
December 1 2025
Last Update
May 15 2025
Active Locations (1)
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1
Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000