Obesity and Obesity-related Medical ConditionsTRIM-IRNCT06856291
Response to Semaglutide in Non-diabetic Obese Patients With Varying Degrees of Insulin Resistance
An observational study of Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by ETH Zurich at 1 site in Switzerland.
Trial summary
Incretin mimetics are widely used pharmacological treatments for weight loss, known for their high efficacy and favorable safety profile. As the most commonly prescribed drug in this class, semaglutide is effective in both diabetic and non-diabetic individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Insulin Sensitivity/Resistance
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2025to 6 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The investigators plan to include a total of 40 non-diabetic, obese individuals that will undergo treatment with semaglutide as a weight-loss intervention independent of our observational study. To avoid a highly heterogeneous participant group, inclusion in the study will be limited to individuals with a BMI between 30 and 40 kg/m². Patients with a prediabetic state will not be excluded.
Who may be able to join
- Age between 18 and 60 years
- BMI 30 - 40 kg/m2
- 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
- Planned therapy with semaglutide as a weight loss intervention
- No known presence of a diabetic state
- Ability to understand and sign a Patient Information and Consent Form
Who cannot join
- Pregnancy or active breast feeding
- 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.
- 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.
- 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)
- Medical conditions that prevent examinations and testing (e.g. epilepsia, symptomatic cardiovascular disease)
- History of or planned bariatric surgery
Show all 15Show fewer
- HbA1c ≥ 6.5% as measured by the central laboratory at screening
- Fasting plasma-glucose >7.0 mmol/l
- History of type 1 or type 2 diabetes mellitus
- Treatment with glucose-lowering agent(s) (e.g. Metformin) within 90 days before screening
- Treatment with a GLP-1 (glucagon like peptide 1) receptor agonist within 180 days before screening
- A self-reported change in body weight >5% within 90 days before screening
- Active malignancy (<2a since remission)
- Treatment with any medication for the indication of obesity within the past 90 days before screening
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Response to Incretin Mimetics in Non-diabetic Obese Patients With and Without Insulin Resistance (TRIM-IR)
Incretin mimetics are widely used pharmacological treatments for weight loss, known for their high efficacy and favorable safety profile. As the most commonly prescribed drug in this class, semaglutide is effective in both diabetic and non-diabetic individuals. However, treatment responses vary significantly, with non-diabetic individuals typically experiencing better weight loss outcomes. Despite this, up to 10% of non-diabetic individuals show little or no response to treatment, and the reasons for this variability remain unclear.
The TRIM-IR study aims to investigate the role of insulin resistance (IR) in weight loss outcomes among non-diabetic obese individuals receiving semaglutide. This single-center, observational study will assess the impact of IR on weight loss, body composition, and adipose tissue function during the first 16 weeks of semaglutide therapy. The study will also explore molecular markers of adipose tissue dysfunction, focusing on the transition from dysfunctional to healthy adipose tissue.
Read more
The investigators hypothesize, that individuals with lower IR will experience greater weight loss than those with higher IR, and that the glucose infusion rate (GIR) during hyperinsulinemic euglycemic clamp testing will correlate with weight loss variability. Secondary objectives include comparing changes in fat and lean mass, reductions in visceral fat, and improvements in adipose tissue function before and after 16 weeks of treatment. Exploratory analyses will assess adipocyte subpopulations and their response to insulin sensitivity changes.
A total of 40 participants, equally distributed by gender, will be enrolled to ensure statistical power for detecting clinically relevant differences. The study aims to optimize semaglutide use for personalized obesity treatment and provide insights into the relationship between obesity, insulin resistance, and adipose tissue plasticity, with implications for improving obesity management and cardiovascular health outcomes.
- Conditions
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Insulin Sensitivity/Resistance, Semaglutide
- Keywords
- Insulin Resistance, incretin mimetics, semaglutide, weight loss, adipose tissue function, obesity, hyperinsulinemic euglycemic clamp, obesity management, insulin sensitivity
- Medical subject headings
- Obesity, Overweight, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic obese individuals on semaglutide for weight loss | Non-diabetic obese individuals with planned semaglutide treatment as a weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (%)
Measured: 16 weeks
Secondary outcomes (3)
Change in fat mass (%)
measured by DEXA (dual energy x-ray absorptiometry)
Measured: 16 weeks
Change in lean mass (%)
measured by DEXA
Measured: 16 weeks
Change in abdominal visceral fat area (in cm2)
measured by DEXA
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start15 Mar 2025
- Primary completion6 Sep 2026
- Study completion6 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Wolfrum, Prof. Dr., Study chair, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856291
- Sponsor's protocol ID
- 2024-02395
- Acronym
- TRIM-IR
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response to Incretin Mimetics in Non-diabetic Obese Patients With and Without Insulin Resistance (TRIM-IR)
- ClinicalTrials.gov ID
- NCT06856291
- Acronym / sponsor ID
- TRIM-IR / 2024-02395
- Conditions
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Insulin Sensitivity/Resistance, Semaglutide
- Keywords
- Insulin Resistance, incretin mimetics, semaglutide, weight loss, adipose tissue function, obesity, hyperinsulinemic euglycemic clamp, obesity management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 6 Sep 2026 (actual)
- Study completion
- 6 Sep 2026 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incretin mimetics are widely used pharmacological treatments for weight loss, known for their high efficacy and favorable safety profile. As the most commonly prescribed drug in this class, semaglutide is effective in both diabetic and non-diabetic individuals. However, treatment responses vary significantly, with non-diabetic individuals typically experiencing better weight loss outcomes. Despite this, up to 10% of non-diabetic individuals show little or no response to treatment, and the reasons for this variability remain unclear.
The TRIM-IR study aims to investigate the role of insulin resistance (IR) in weight loss outcomes among non-diabetic obese individuals receiving semaglutide. This single-center, observational study will assess the impact of IR on weight loss, body composition, and adipose tissue function during the first 16 weeks of semaglutide therapy. The study will also explore molecular markers of adipose tissue dysfunction, focusing on the transition from dysfunctional to healthy adipose tissue.
The investigators hypothesize, that individuals with lower IR will experience greater weight loss than those with higher IR, and that the glucose infusion rate (GIR) during hyperinsulinemic euglycemic clamp testing will correlate with weight loss variability. Secondary objectives include comparing changes in fat and lean mass, reductions in visceral fat, and improvements in adipose tissue function before and after 16 weeks of treatment. Exploratory analyses will assess adipocyte subpopulations and their response to insulin sensitivity changes.
A total of 40 participants, equally distributed by gender, will be enrolled to ensure statistical power for detecting clinically relevant differences. The study aims to optimize semaglutide use for personalized obesity treatment and provide insights into the relationship between obesity, insulin resistance, and adipose tissue plasticity, with implications for improving obesity management and cardiovascular health outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic obese individuals on semaglutide for weight loss | – | –Non-diabetic obese individuals with planned semaglutide treatment as a weight loss intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators plan to include a total of 40 non-diabetic, obese individuals that will undergo treatment with semaglutide as a weight-loss intervention independent of our observational study. To avoid a highly heterogeneous participant group, inclusion in the study will be limited to individuals with a BMI between 30 and 40 kg/m². Patients with a prediabetic state will not be excluded.
Key inclusion criteria (6 listed)
- Age between 18 and 60 years
- BMI 30 - 40 kg/m2
- Planned therapy with semaglutide as a weight loss intervention
- No known presence of a diabetic state
- Ability to understand and sign a Patient Information and Consent Form
Key exclusion criteria (15 listed)
- Pregnancy or active breast feeding
- 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)
- Medical conditions that prevent examinations and testing (e.g. epilepsia, symptomatic cardiovascular disease)
- History of or planned bariatric surgery
- HbA1c ≥ 6.5% as measured by the central laboratory at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in body weight (%)
Time frame: 16 weeks
3 secondary outcomes
Change in fat mass (%)
Time frame: 16 weeks
Change in lean mass (%)
Time frame: 16 weeks
Change in abdominal visceral fat area (in cm2)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Wolfrum, Prof. Dr. study chair
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by ETH Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (%) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.