Response to Semaglutide in Non-diabetic Obese Patients With Varying Degrees of Insulin Resistance

Launched by ETH ZURICH · Feb 26, 2025

Keywords

ClinConnect Summary

The TRIM-IR study is looking at how insulin resistance (a condition where the body's cells don't respond well to insulin) affects weight loss in non-diabetic people who are obese and taking a medication called semaglutide. Semaglutide is a treatment that helps with weight loss, but not everyone responds the same way. Researchers want to understand why some people lose more weight than others when using this medication. Over 16 weeks, the study will track changes in weight, body composition, and how fat tissue functions in 40 participants, both men and women, aged 18 to 60, who have a body mass index (BMI) between 30 and 40 and have related health conditions.

To join the study, participants must be non-diabetic and have no recent significant changes in weight or treatment for obesity. During the study, participants will receive semaglutide and undergo various tests to see how their body responds to the treatment. This research could help tailor weight loss treatments to individuals based on their insulin sensitivity, potentially leading to better management of obesity and related health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 60 years
• • 2. BMI 30 - 40 kg/m2
• • a. Participants must meet the eligibility criteria for coverage under the KVG (Federal Health Insurance Act) and the Specialties List, which include a weight-related comorbidity (arterial hypertension, dyslipidemia) for participants with a BMI of 30- 35 kg/m2
• • 3. Planned therapy with semaglutide as a weight loss intervention
• • 4. No known presence of a diabetic state
• • 5. Ability to understand and sign a Patient Information and Consent Form
• Exclusion Criteria:
• • 1. Pregnancy or active breast feeding
• • 1. Therapy with semaglutide is not approved for use during pregnancy or while breastfeeding, as its safety and efficacy in these conditions have not been established.
• • 2. Pregnancy is an exclusion criterion for the planned investigations to avoid placing pregnant individuals under unnecessary physical or psychological stress that could pose risks to both the individual and the fetus.
• • 2. Medication and/or pathologies that prevent the safe execution of the fat tissue biopsies (e.g. allergy towards local anesthetics, disorders of coagulation, treatment with anticoagulants)
• • 3. Medical conditions that prevent examinations and testing (e.g. epilepsia, symptomatic cardiovascular disease)
• • 4. History of or planned bariatric surgery
• • 5. HbA1c ≥ 6.5% as measured by the central laboratory at screening
• • 6. Fasting plasma-glucose \>7.0 mmol/l
• • 7. History of type 1 or type 2 diabetes mellitus
• • 8. Treatment with glucose-lowering agent(s) (e.g. Metformin) within 90 days before screening
• • 9. Treatment with a GLP-1 (glucagon like peptide 1) receptor agonist within 180 days before screening
• • 10. A self-reported change in body weight \>5% within 90 days before screening
• • 11. Active malignancy (\<2a since remission)
• • 12. Treatment with any medication for the indication of obesity within the past 90 days before screening
• • 13. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) \> 10 mIU/L or \< 0.4 mIU/L as measured by the central laboratory at screening