Effect of Tirzepatide on Brown Adipose Tissue in Obesity

Sponsor
University Medical Centre Ljubljana
Study ID
NCT06893211
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It will be administered via subcutaneous injection once weekly in a dose-titration scheme: starting at 2.5 mg, and increased every 4 weeks by 2.5 mg up to a maximum of 15 mg, based on tolerability. The medication will be supplied in prefilled pens identical in appearance to placebo pens.
  • Placebo — DRUG
    Placebo will be administered via subcutaneous injection once weekly using pens that are visually indistinguishable from those used for tirzepatide. Dose escalation will follow the same schedule (2.5 mg-equivalent increments every 4 weeks) to preserve blinding integrity.

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
May 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Brown Adipose Tissue Activity and Volume [ Time Frame: Baseline to Week 24 ]

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