NCT07761923

Brief Summary

Treatment with appetite suppressant drugs, including incretin-based receptor agonists, generally leads to clinically meaningful weight loss and reduced cardiometabolic risk. However, weight loss may include not only loss of adipose tissue but also loss of skeletal muscle mass, which ultimately 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 appetite suppressant obesity medications have been studied insufficiently. This study will investigate whether unilateral resistance training during incretin-based receptor agonist treatment can preserve or improve skeletal muscle mass. Additionally, the study will determine whether preservation of muscle is accompanied by the preservation of muscle function and/or molecular adaptations in skeletal muscle, adipose tissue and blood. Participants will be adults 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 two times per week, training one leg while the other leg serves as an internal control. Data and tissue collection will take place before treatment start and after 13 weeks. Assessments include whole-body magnetic resonance imaging, blood sampling, skeletal muscle and adipose tissue biopsies, physical function tests, questionnaires, and monitoring of physical activity.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

August 12, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 30, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

ObesityIncretinsSkeletal muscleResistance trainingExercise training

Outcome Measures

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.

    From baseline to 13 weeks

Secondary Outcomes (8)

  • Change in knee extension strength

    From baseline to 13 weeks

  • Change in muscle fatigue tolerance

    From baseline to 13 weeks

  • Change in whole-body skeletal muscle mass

    From baseline to 13 weeks

  • Change in total body fat volume

    From baseline to 13 weeks

  • Change in liver fat fraction

    From baseline to 13 weeks

  • +3 more secondary outcomes

Other Outcomes (14)

  • Change in body mass

    From baseline to 13 weeks

  • Change in blood pressure

    From baseline to 13 weeks

  • Change in skeletal muscle molecular profile

    From baseline to 13 weeks

  • +11 more other outcomes

Study Arms (1)

Incretin treatment combined with unilateral resistance training

EXPERIMENTAL

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

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.

Incretin treatment combined with unilateral resistance training

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-64 years with obesity.
  • 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 informed consent in the Swedish language.

You may not qualify if:

  • Contraindication to magnetic resonance imaging.
  • Medical condition preventing resistance training or physical function testing.
  • Medical condition preventing skeletal muscle or adipose tissue biopsy.
  • Inability to understand study information in Swedish or provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eric B Emanuelsson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants undergo incretin-based receptor agonist treatment as part of routine clinical care and complete a 13-week unilateral leg resistance training intervention. One leg is trained and the contralateral leg serves as an internal within-participant control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

August 12, 2026

Record last verified: 2026-07

Locations