ClinicalTrials.gg
RecruitingNCT07761923INCRETraINUpdated Nov 3, 2026

Preserving Muscle Mass During Incretin-Induced Weight Loss

An interventional study of Unilateral Resistance Training in Obesity (BMI > 35), sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Now RecruitingSite recruiting status changed+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
Female
01

Study summary

Treatment with incretin-based obesity medications leads to clinically meaningful weight loss and reduced cardiometabolic risk. However, the weight lost includes not only adipose tissue but also skeletal muscle, which may impair physical function and metabolic health.

Resistance training is an effective strategy to maintain or increase skeletal muscle mass during weight loss, but its effects during treatment with incretin-based obesity medications have not been studied. This study will investigate whether unilateral resistance training during incretin-based receptor agonist treatment can preserve or improve skeletal muscle volume. The study will also examine whether training affects muscle strength and fatigue tolerance, body composition, cardiac structure and function, and molecular profiles in skeletal muscle, adipose tissue and blood.

Participants will be women with obesity who are about to start treatment with an incretin-based receptor agonist as part of routine clinical care. During the 13-week intervention, participants will perform supervised unilateral resistance training twice weekly, training one leg while the other leg serves as an internal control. Assessments before treatment start and after 13 weeks include whole-body and cardiac magnetic resonance imaging, blood sampling, skeletal muscle and adipose tissue biopsies, knee-extensor strength and fatigue tests, and questionnaires. An additional intermediate sampling of blood and tissue (week 4-6) will be collected only in participants who consent to an extra visit.

02

Conditions studied

  • Obesity (BMI > 35)

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Keywords

  • Obesity
  • Incretins
  • Skeletal muscle
  • Resistance training
  • Exercise training
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 20 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 16, 2026. See what changed

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 18-64 years with obesity, ≥35 kg/m²
  • Planned initiation of incretin-based obesity pharmacotherapy as part of routine clinical care.
  • Able to participate in supervised unilateral resistance training.
  • Able to complete physical function tests.
  • Able to attend study visits at the study center.
  • Able to provide written in the Swedish language.

Exclusion criteria

Exclusion Criteria:

  • to magnetic resonance imaging.
  • Medical condition preventing resistance training or physical-function testing.
  • Medical condition preventing skeletal muscle or adipose-tissue .
  • A weight reduction >5% during the last 3 months.
  • Patients diagnosed with any known serious chronic illness, including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose >7 mmol/L).
  • Angina pectoris, coronary heart disease or congestive heart failure ( Class III- IV).
  • Severe renal impairment ( () \<30 mL/min).
  • Severe hepatic impairment.
  • Inflammatory bowel disease.
  • Gastroparesis.
  • Cancer.
  • Chronic obstructive lung disease.
  • Severe psychiatric disorders.
  • Previous bariatric surgery.
  • A history of idiopathic acute pancreatitis.
  • The use of medications that cause weight gain or loss.
  • A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
  • Osteoarthritis, which is judged to be too severe to manage the exercise programme.
  • Pregnancy, expecting pregnancy or breast feeding.
  • to the planned incretin-based medication or any of its .
  • Regular exercise training at high intensity (eg, spinning) >2 hours per week.
  • Inability to understand the study information in Swedish or provide .
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Incretin treatment combined with unilateral resistance training

    Participants will initiate incretin-based receptor agonist treatment as part of routine clinical care. The study intervention consists of supervised unilateral resistance training performed twice weekly for 13 weeks. No incretin-based medication is assigned or administered by the study.

    Behavioral: Unilateral Resistance Training

Interventions

  • BehavioralUnilateral Resistance Training

    Supervised resistance training of one leg, two sessions per week for 13 weeks, during incretin-based receptor agonist treatment. The trained leg will be randomly assigned, and the contralateral leg will serve as an internal within-participant control.

06

What researchers measure

Primary outcomes

  1. Change in Anterior Thigh Skeletal Muscle Volume

    Change in skeletal muscle volume (L) of the anterior thigh muscles, measured by magnetic resonance imaging from baseline to 13 weeks. The primary comparison will be the difference in change from baseline to 13 weeks between the trained leg and the untrained contralateral leg. Images are analysed by an independent image-analysis service using standardised, automated segmentation, blinded to which leg was trained.

    Time frame: From baseline to 13 weeks

Secondary outcomes

  1. Change in isometric knee extension strength

    Change in lower-limb muscle strength measured using isometric (Nm) knee extension tests.

    Time frame: From baseline to 13 weeks

  2. Change in isokinetic knee extension strength

    Change in lower-limb muscle strength measured using isokinetic (Nm) knee extension tests at 60°/s and 270°/s (Nm).

    Time frame: From baseline to 13 weeks

  3. Change in muscle fatigue tolerance

    Change in peak torque (Nm) during repeated maximal concentric isokinetic contractions at 180°/s, assessed over 30 repetitions. Initial peak torque will be defined as the highest peak torque recorded during the first three repetitions, and final peak torque will be defined as the mean peak torque recorded during the last five repetitions. The decline in torque-generating capacity will be calculated as the absolute and relative decrease from initial to final peak torque.

    Time frame: From baseline to 13 weeks

  4. Change in whole-body skeletal muscle volume

    Change in whole-body skeletal muscle volume (L) measured by magnetic resonance imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation.

    Time frame: From baseline to 13 weeks

  5. Change in total body fat volume

    Change in total body fat volume (L) measured by magnetic resonance imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation.

    Time frame: From baseline to 13 weeks

  6. Change in liver fat fraction

    Change in liver fat fraction (%) measured by magnetic resonance imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation.

    Time frame: From baseline to 13 weeks

  7. Change in abdominal subcutaneous adipose tissue volume

    Change in abdominal subcutaneous adipose tissue volume (L), measured by magnetic resonace imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation.

    Time frame: From baseline to 13 weeks

  8. Change in visceral adipose tissue volume

    Change in visceral adipose tissue volume (L) measured by magnetic resonance imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation.

    Time frame: From baseline to 13 weeks

  9. Change in skeletal muscle fat infiltration

    Change in anterior thigh muscle fat infiltration (%), measured by magnetic resonance imaging. Images are analysed by an independent image-analysis service using standardised, automated segmentation, blinded to which leg was trained.

    Time frame: From baseline to 13 weeks

Other outcomes

  1. Change in body mass

    Change in body mass during the intervention (kg).

    Time frame: From baseline to 13 weeks

  2. Change in blood pressure

    Change in resting systolic and diastolic blood pressure (mmHg).

    Time frame: From baseline to 13 weeks

  3. Change in skeletal muscle molecular profile

    Changes in molecular markers in skeletal muscle, including global (transcriptomics, proteomics, phosphoproteomics and metabolomics) and targeted gene expression, protein abundance, and specific molecular pathways. The intermediate sample (optional - only collected in participants who consent to the additional visit) is collected between week 4 and week 6 after the first dose.

    Time frame: Baseline, 4-6 weeks and 13 weeks

  4. Change in adipose tissue molecular profile

    Changes in molecular markers in subcutaneous adipose tissue, including gene expression (transcriptomics), proteins (proteomics \& phosphoproteomics), metabolites (metabolomics), inflammatory markers, and specific molecular pathways. The intermediate sample (optional) is collected between week 4 and week 6 after the first dose.

    Time frame: Baseline, 4-6 weeks and 13 weeks

  5. Change in health-related quality of life (RAND-36)

    Change in health-related quality of life using RAND-36. Each dimension results in a score from 0 to 100 (higher = better score).

    Time frame: From baseline to 13 weeks

  6. Change in health-related quality of life (EQ-5D-5L)

    Change in health-related quality of life using EQ-5D-5L. Each dimension results in a score from 1 (no problems) to 5 (extreme problems). The EQ visual analogue scale is rated from 0 (worst health you can imagine) to 100 (best health you can imagine)

    Time frame: From baseline to 13 weeks

  7. Change in cardiometabolic blood markers

    Change in blood markers including clinically relevant metabolic, inflammatory, endocrine and cardiovascular biomarkers. The intermediate sample is collected between week 4 and week 6 after the first dose. The intermediate sample (optional) is collected between week 4 and week 6 after the first dose.

    Time frame: Baseline, 4-6 weeks and 13 weeks

  8. Change in energy intake and nutrient composition

    Change in self-reported energy intake (kcal), macronutrient intake, and micronutrient intake, measured by a food frequency questionnaire from baseline to 13 weeks.

    Time frame: From baseline to 13 weeks

  9. Change in physical activity

    Change in self-reported daily physical activity (minutes per week).

    Time frame: From baseline to 13 weeks

  10. Change in mitochondrial content

    Change in tissue (skeletal muscle and adipose tissue) mitochondrial content measured by citrate synthase activity (nmol/min/mg protein). The intermediate sample (optional) is collected between week 4 and week 6 after the first dose.

    Time frame: Baseline, 4-6 weeks and 13 weeks

  11. Change in immune cell populations

    Change in circulating immune cell populations. The intermediate sample is collected between week 4 and week 6 after the first dose. The intermediate sample (optional) is collected between week 4 and week 6 after the first dose.

    Time frame: Baseline, 4-6 weeks and 13 weeks

  12. Change in sedentary time

    Change in self-reported daily physical inactivity, measured as hours per day.

    Time frame: From baseline to 13 weeks.

  13. Change in total blood volume

    Change in total blood volume measured by using the carbon monoxide-rebreathing method.

    Time frame: From baseline to 13 weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified individual participant data may be made available upon reasonable request after publication, depending on ethical approval, participant consent, Swedish and EU data protection regulations, and institutional policies at Karolinska Institutet and Region Stockholm.

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
1 site added, 1 site removed. Karolinska University Hospital Huddinge is now Recruiting
Show site
  • Karolinska University Hospital Huddinge · Stockholm, Sweden
Show 1 removed
  • Karolinska Institutet · Stockholm, Sweden
across 2 updates, Oct 16, 2026 – Nov 3, 2026
Start date
Sep 1, 2026→Oct 27, 2026 (actual)
moved 2 times, Oct 16, 2026 – Nov 3, 2026
Eligibility
Sex ALL→FEMALE; 1 inclusion criterion edited; 3 exclusion criteria edited, 18 added
What changed in the criteria
Inclusion criteria
  • EditedAdultsWomen aged 18-64 years with obesity., BMI ≥35 kg/m²
Exclusion criteria
  • EditedMedical condition preventing resistance training or physical -function testing.
  • EditedMedical condition preventing skeletal muscle or adipose -tissue biopsy.
  • AddedA weight reduction >5% during the last 3 months.
  • AddedPatients diagnosed with any known serious chronic illness, including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose >7 mmol/L).
  • AddedAngina pectoris, coronary heart disease or congestive heart failure (NYHA Class III- IV).
  • AddedSevere renal impairment (creatinine clearance (GFR) <30 mL/min).
  • AddedSevere hepatic impairment.
  • AddedInflammatory bowel disease.
  • AddedGastroparesis.
  • AddedCancer.
  • AddedChronic obstructive lung disease.
  • AddedSevere psychiatric disorders.
  • AddedPrevious bariatric surgery.
  • AddedA history of idiopathic acute pancreatitis.
  • AddedThe use of medications that cause clinically significant weight gain or loss.
  • AddedA family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
  • AddedOsteoarthritis, which is judged to be too severe to manage the exercise programme.
  • AddedPregnancy, expecting pregnancy or breast feeding.
  • AddedHypersensitivity to the planned incretin-based medication or any of its excipients.
  • AddedRegular exercise training at high intensity (eg, spinning) >2 hours per week.
  • EditedInability to understand the study information in Swedish or provide informed consent.
Oct 16, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Anterior Thigh Skeletal Muscle Volume: how it is measured was reworded
Oct 16, 2026
Secondary outcomes
Revised in 2 updates
What changed on Oct 16, 2026
  • EditedChange in isometric knee extension strengthTime frame: From baseline to 13 weeks
  • EditedChange in whole-body skeletal muscle massvolumeTime frame: From baseline to 13 weeks
  • EditedChange in skeletal muscle fat fractioninfiltrationTime frame: From baseline to 13 weeks
  • AddedChange in isokinetic knee extension strengthTime frame: From baseline to 13 weeks
  • DescriptionChange in abdominal subcutaneous adipose tissue volume: how it is measured was reworded
  • DescriptionChange in liver fat fraction: how it is measured was reworded
  • DescriptionChange in total body fat volume: how it is measured was reworded
  • DescriptionChange in visceral adipose tissue volume: how it is measured was reworded
  • Addedother outcomeChange in total blood volumeTime frame: From baseline to 13 weeks.
  • Time frameother outcomeChange in skeletal muscle molecular profileFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
  • Time frameother outcomeChange in adipose tissue molecular profileFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
  • Time frameother outcomeChange in cardiometabolic blood markersFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
  • Time frameother outcomeChange in mitochondrial contentFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
  • Time frameother outcomeChange in immune cell populationsFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
  • Descriptionother outcomeChange in adipose tissue molecular profile: how it is measured was reworded
  • Descriptionother outcomeChange in cardiometabolic blood markers: how it is measured was reworded
  • Descriptionother outcomeChange in immune cell populations: how it is measured was reworded
  • Descriptionother outcomeChange in mitochondrial content: how it is measured was reworded
  • Descriptionother outcomeChange in skeletal muscle molecular profile: how it is measured was reworded
What changed on Oct 29, 2026
  • Removedother outcomeChange in mitochondrial respiratory capacityTime frame: From baseline to 13 weeks
  • Removedother outcomeChange in fat cell metabolismTime frame: From baseline to 13 weeks
across 2 updates, Oct 16, 2026 – Oct 29, 2026
Show all 3 updates
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    Karolinska University Hospital Huddinge is now Recruiting
    Start date Oct 21, 2026→Oct 27, 2026 (now actual)
  2. Oct 29, 2026
    Secondary outcomes 2 removed
    What changed in the outcomes
    • Removedother outcomeChange in mitochondrial respiratory capacityTime frame: From baseline to 13 weeks
    • Removedother outcomeChange in fat cell metabolismTime frame: From baseline to 13 weeks
  3. Oct 16, 2026
    1 site added, 1 site removed
    Show site
    • Karolinska University Hospital Huddinge · Stockholm, Sweden
    Show 1 removed
    • Karolinska Institutet · Stockholm, Sweden
    Start date Sep 1, 2026→Oct 21, 2026
    Eligibility Sex ALL→FEMALE; 1 inclusion criterion edited; 3 exclusion criteria edited, 18 added
    What changed in the criteria
    Inclusion criteria
    • EditedAdultsWomen aged 18-64 years with obesity., BMI ≥35 kg/m²
    Exclusion criteria
    • EditedMedical condition preventing resistance training or physical -function testing.
    • EditedMedical condition preventing skeletal muscle or adipose -tissue biopsy.
    • AddedA weight reduction >5% during the last 3 months.
    • AddedPatients diagnosed with any known serious chronic illness, including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose >7 mmol/L).
    • AddedAngina pectoris, coronary heart disease or congestive heart failure (NYHA Class III- IV).
    • AddedSevere renal impairment (creatinine clearance (GFR) <30 mL/min).
    • AddedSevere hepatic impairment.
    • AddedInflammatory bowel disease.
    • AddedGastroparesis.
    • AddedCancer.
    • AddedChronic obstructive lung disease.
    • AddedSevere psychiatric disorders.
    • AddedPrevious bariatric surgery.
    • AddedA history of idiopathic acute pancreatitis.
    • AddedThe use of medications that cause clinically significant weight gain or loss.
    • AddedA family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
    • AddedOsteoarthritis, which is judged to be too severe to manage the exercise programme.
    • AddedPregnancy, expecting pregnancy or breast feeding.
    • AddedHypersensitivity to the planned incretin-based medication or any of its excipients.
    • AddedRegular exercise training at high intensity (eg, spinning) >2 hours per week.
    • EditedInability to understand the study information in Swedish or provide informed consent.
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Anterior Thigh Skeletal Muscle Volume: how it is measured was reworded
    Secondary outcomes 3 edited, 5 time frame changed, 2 added, 9 description edited
    What changed in the outcomes
    • EditedChange in isometric knee extension strengthTime frame: From baseline to 13 weeks
    • EditedChange in whole-body skeletal muscle massvolumeTime frame: From baseline to 13 weeks
    • EditedChange in skeletal muscle fat fractioninfiltrationTime frame: From baseline to 13 weeks
    • AddedChange in isokinetic knee extension strengthTime frame: From baseline to 13 weeks
    • DescriptionChange in abdominal subcutaneous adipose tissue volume: how it is measured was reworded
    • DescriptionChange in liver fat fraction: how it is measured was reworded
    • DescriptionChange in total body fat volume: how it is measured was reworded
    • DescriptionChange in visceral adipose tissue volume: how it is measured was reworded
    • Addedother outcomeChange in total blood volumeTime frame: From baseline to 13 weeks.
    • Time frameother outcomeChange in skeletal muscle molecular profileFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
    • Time frameother outcomeChange in adipose tissue molecular profileFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
    • Time frameother outcomeChange in cardiometabolic blood markersFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
    • Time frameother outcomeChange in mitochondrial contentFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
    • Time frameother outcomeChange in immune cell populationsFrom baseline to 13 weeks → Baseline, 4-6 weeks and 13 weeks
    • Descriptionother outcomeChange in adipose tissue molecular profile: how it is measured was reworded
    • Descriptionother outcomeChange in cardiometabolic blood markers: how it is measured was reworded
    • Descriptionother outcomeChange in immune cell populations: how it is measured was reworded
    • Descriptionother outcomeChange in mitochondrial content: how it is measured was reworded
    • Descriptionother outcomeChange in skeletal muscle molecular profile: how it is measured was reworded
    + 3 other changes: verification date, description and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07761923
Collaborators
Region Stockholm
Responsible party
Eric Emanuelsson (Postdoctoral Researcher, Karolinska Institutet) — Principal investigator
First posted
Aug 12, 2026
Start date
Oct 27, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Eric B Emanuelsson, PhD
Contact
eric.emanuelsson@ki.se
+46730266626

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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