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Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide

ConditionObesity (BMI>30)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTechnical University of Munich

About this trial

Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects. The aim of this clinical trial is to examine the effects of resistance training versus standard of care on contractile thigh muscle volume in patients receiving the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists 'tirzepatide'.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are ≥ 18 years and ≤ 60 years of age

Have a body mass index (BMI) of ≥ 30 kg/m2

Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

In the investigator's opinion, are well motivated, capable, and willing to

Disqualifiers

Have known Type 1 Diabetes, a history of Type 2 Diabetes (including those in remission), a history of ketoacidosis of any aetiology, or a history of hyperosmolar hyperglycaemic state or coma

glycated hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol)

fasting glucose ≥126 mg/dL (≥7.0 mmol/L) Note: If a blood sample is collected under non-fasting conditions and the random glucose value is ≥200 mg/dL (≥11.1 mmol/L), an additional fasting blood sample will be obtained to confirm or exclude diabetes.

Have a self-reported reduction in body weight >5 kg within 3 months prior to screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual GIP/GLP-1 Receptor Agonist Tirzepatide

    Drug

    Tirzepatide will be titrated to a maximum tolerated dose of up to 10 mg/week (+2.5 mg/week every 4 weeks) and accomponied by regular individual diet and physical activity counseling

  • Resistance Training

    Behavioral

    Low-volume, high-intensity resistance training on 3 days/week

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Dual GIP/GLP-1 Receptor Agonist TirzepatideActive comparator 1 intervention
Group B: Dual GIP/GLP-1 Receptor Agonist Tirzepatide + Resistance TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in contractile thigh muscle volume (mL), as assessed by magnetic resonance imaging (MRI)

Time frame
From baseline to the end of treatment at 24 weeks

Secondary outcomes

1

Change in body weight (kg), as assessed by a calibrated scale

Time frame
From baseline to the end of treatment at 24 weeks
2

Change in anterior thigh intramuscular fat fraction (%), as assessed by MRI

Time frame
From baseline to the end of treatment at 24 weeks
3

Change in contractile muscle volume of the combined scapular and upper back musculature (mL), as assessed by MRI

Time frame
From baseline to the end of treatment at 24 weeks
4

Change in combined whole-trunk and thigh fat volume (mL), as assessed by MRI

Time frame
From baseline to the end of treatment at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technical University of Munich

Lead sponsor

EGYM SE

Collaborator

Source ClinicalTrials.gov
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