Obesity (BMI>30)Phase 4RESISTNCT07777575
Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide
A Phase 4 study testing Dual GIP/GLP-1 Receptor Agonist Tirzepatide and Resistance Training in people with Obesity (BMI>30), run by Technical University of Munich at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity (BMI>30)
- What is being tested?
- Dual GIP/GLP-1 Receptor Agonist Tirzepatide and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2026to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age
- Are ≥ 18 years and ≤ 60 years of age
- Weight
- 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
Show all 18Show fewer
- learn how to self-inject the investigational medicinal product (IMP), as required for this protocol
- inject the IMP, and
- comply with trial procedures for the duration of the trial, including adherence to scheduled visits, the prescribed resistance training program (if assigned to the experimental group), lifestyle recommendations, and other requirements as specified in the protocol
- Sex and contraceptive/barrier requirements [only for women]
- Women of childbearing potential (WOCBP) may be enrolled only if one of the following applies:
- They are completely abstinent as their preferred and usual lifestyle or exclusively in a same-sex relationship as their preferred and usual lifestyle and agree to remain abstinent or stay in a same-sex relationship without sexual relationships with males until 30 days after the last injection (> 5 half-lives of tirzepatide)
- They have a negative serum pregnancy test result at screening followed by a negative urine result ≤ 24 hours prior to the first injection, and they agree to use, from screening until 30 days after the last injection, either:
- one highly effective method of contraception (failure rate <1% per year) or
- two complementary forms of effective contraception Note: The summary of product characteristics (SmPC) indicates that concomitant use with tirzepatide may reduce systemic exposure to oral contraceptives, particularly during dose escalation, potentially decreasing their contraceptive effectiveness. Therefore, the use of a barrier method in combination with oral contraceptives is required.
- Informed Consent
- Are sufficiently proficient in German to understand the trial procedures and informed consent information
- Are capable of providing written informed consent
Who cannot join
- Medical Conditions Diabetes Related
- 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
- Have at least one laboratory value suggestive of diabetes during screening including:
- 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.
- Obesity Related
Show all 49Show fewer
- Have a self-reported reduction in body weight >5 kg within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
- Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner)
- Have obesity induced by other known endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader Willi Syndrome) Note: If endocrinological disorder is suspected, a dexamethasone suppression test should be performed to assess for possible hypercortisolism
- Other Medical
- Are currently breastfeeding
- Have structural cardiovascular disease (e.g., ischemic cardiovascular disease, heart failure, previous cerebrovascular accident [stroke])
- Have atrial fibrillation
- Have uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)
- Have any visual, neurological, musculoskeletal, or other physical impairment that, in the opinion of the investigator, would prevent the participant from independently and appropriately self-administering the IMP and/or performing the resistance training program as required by the protocol (e.g., significant muscle or joint pain, significantly limited range of motion)
- Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 creatinine-based equation during screening
- Have a known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility
- Have a history of chronic or acute pancreatitis Note: If acute pancreatitis is suspected, laboratory assessment of pancreatic amylase and/or lipase
- Have thyroid-stimulating hormone (TSH) outside the range of 0.4 to 6.0 mIU/L at the screening visit Note: Participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 3 months and their TSH at screening falls within the range indicated above.
- Note: Participants with a history of subclinical hypothyroidism but a TSH at screening within the range indicated above may be included if, in the investigator's opinion, the participant is unlikely to require initiation of thyroid hormone replacement during the course of the study.
- Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or other serious mood or anxiety disorder within the last 2 years Note: Participants with major depressive disorder or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.
- Have a PHQ-9 score of 15 or more during screening
- Have acute suicidality, defined as endorsement of Item 4 and/or Item 5 of the Columbia-Suicide-Severity Scale (C-SSRS) at screening, or any condition that, in the judgment of the investigator, indicates a significant and immediate risk of suicide Note: The C-SSRS will only be assessed if PHQ-9 Item 9 is greater than 0
- Have a history of lifetime suicidal behavior, defined as any positive response within the "Suicidal Behavior" section of the C-SSRS (except non-suicidal self-injurious behavior) Note: The C-SSRS will only be assessed if PHQ-9 Item 9 is greater than 0
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than metabolic dysfunction-associated fatty liver disease (MAFLD), or any of the following, as determined during screening:
- Alanine aminotransferase (ALAT) level >3.0x upper limit of normal (ULN) for the reference range
- Total bilirubin (TBL) level >1.5x ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: If cholestatic liver disease is suspected, alkaline phosphatase level (ALP) must be <1.5x ULN for the reference range.
- Note: Participants with MAFLD are eligible to participate in this trial if their ALAT level is ≤3.0x ULN for the reference range.
- Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2 or a serum calcitonin level during screening of:
- ≥20 ng/L, if eGFR ≥60 mL/min/1.73 m2, or
- ≥35 ng/L, if eGFR <60 mL/min/1.73 m2
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- Have a history of any other condition, such as known drug, alcohol, or substance abuse (including regular use of marijuana or tetrahydrocannabinol-containing products), a diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may interfere with the participant's ability to comply with and/or complete the protocol
- Have had a transplanted organ (other than corneal transplants [keratoplasty]) or awaiting an organ transplant
- Have any clinically significant hematological condition that may interfere with accurate HbA1c measurement or interpretation (e.g., hemolytic anemias or sickle cell disease)
- Have any other medical condition not listed above that, based on current clinical guidelines or in the opinion of the investigator, constitutes a contraindication to moderate-to-high intensity resistance training (e.g., active proliferative retinopathy, unstable musculoskeletal, neurological, or cardiovascular conditions, or other conditions associated with an increased risk of serious adverse events during resistance exercise)
- Prior/concomitant therapy
- Have previously used a GLP-1 receptor agonist or a dual incretin receptor agonist at any time
- Are currently receiving, or have received within 3 months prior to screening, chronic systemic glucocorticoid therapy (>14 days), or have a clinically significant active autoimmune disease (e.g., lupus or rheumatoid arthritis) that, in the opinion of the investigator, requires or is likely to require systemic glucocorticoid treatment during the trial Note: Topical, intraocular, intranasal, intra-articular, or inhaled glucocorticoids are allowed
- Have current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain, including but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.
- Have taken, within 3 months prior to screening, medications (other than GLP-1 or dual GIP/GLP-1 receptor agonists) or alternative remedies that promote weight loss Note: Use of metformin or any other glucose-lowering medication, whether prescribed for polycystic ovary syndrome or diabetes prevention, is not permitted.
- Prior/concurrent clinical study / resistance training experience
- Are currently enrolled in any other clinical study involving an IMP or any other type of medical research judged not to be scientifically or medically compatible with this clinical trial
- Within the last 30 days of screening, have participated in a clinical trial and received treatment, whether active, or placebo. If the trial involved an IMP, 5 half-lives or 30 days, whichever is longer, should have passed.
- Have participated in structured resistance training program (≥ 2x/week for ≥ 4 consecutive weeks) within the last 3 months
- Other exclusions
- Have any contraindication to MRI (e.g., non-MRI-compatible implanted devices, metallic foreign bodies, severe claustrophobia, or body size exceeding MRI scanner limitations [maximum bore diameter 70 cm])
- Have a planned absence of ≥14 consecutive days (or a total of ≥ 30 days) within the next 6 months that would prevent adherence to scheduled trial visits and/or the training intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Technischen Universität München (TUM Klinikum)
München, Bavaria, 80809
Stephan Mueller-Stegner, Dr rer nat, +49 (0)89 289-24494, stephan.mueller@mri.tum.de
Martin Halle, MD
About this study
Official title: A Phase IV, Randomized Controlled Trial to Evaluate the Effects of Resistance Training Versus Usual Care on Thigh Muscle Volume During Treatment With the Dual GIP/GLP-1 Receptor Agonist Tirzepatide in Adults With Obesity
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'.
- Conditions
- Obesity (BMI>30)
- Being tested
- Dual GIP/GLP-1 Receptor Agonist Tirzepatide, Resistance Training
- Keywords
- skeletal muscle, weight loss, exercise training, strength training, incretin-based therapy
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual GIP/GLP-1 Receptor Agonist TirzepatideDrug
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 TrainingBehavioural
Low-volume, high-intensity resistance training on 3 days/week
| Study group | Role | What they receive |
|---|---|---|
| Dual GIP/GLP-1 Receptor Agonist Tirzepatide | Active comparator | Not described Receives: Drug: Dual GIP/GLP-1 Receptor Agonist Tirzepatide |
| Dual GIP/GLP-1 Receptor Agonist Tirzepatide + Resistance Training | Experimental | Not described Receives: Drug: Dual GIP/GLP-1 Receptor Agonist Tirzepatide; Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contractile thigh muscle volume (mL), as assessed by magnetic resonance imaging (MRI)
Measured: From baseline to the end of treatment at 24 weeks
Secondary outcomes (21)
Change in body weight (kg), as assessed by a calibrated scale
Measured: From baseline to the end of treatment at 24 weeks
Change in anterior thigh intramuscular fat fraction (%), as assessed by MRI
Measured: From baseline to the end of treatment at 24 weeks
Change in contractile muscle volume of the combined scapular and upper back musculature (mL), as assessed by MRI
Measured: From baseline to the end of treatment at 24 weeks
Change in combined whole-trunk and thigh fat volume (mL), as assessed by MRI
Measured: From baseline to the end of treatment at 24 weeks
Change in peak isometric knee extension torque (Nm), as assessed using an isokinetic dynamometer
Measured: From baseline to the end of treatment at 24 weeks
Change in maximum handgrip strength (kg), as assessed by a hand dynamometer
Measured: From baseline to the end of treatment at 24 weeks
Change in the number of chair stands, as assessed by the 30-second chair stand test
Measured: From baseline to the end of treatment at 24 weeks
Change in usual gait speed (m/s), as assessed by the time required to walk 10 meters
Measured: From baseline to the end of treatment at 24 weeks
Change in physical health-related QoL, as assessed by the Physical Component Summary score of the Short-Form-36 Health Survey, Version 2, Acute Form (SF-36v2)
Measured: From baseline to the end of treatment at 24 weeks
Change in mental health-related QoL, as assessed by the Mental Component Summary score of the SF-36v2
Measured: From baseline to the end of treatment at 24 weeks
Change in obesity-specific QoL, as assessed by the Total Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Measured: From baseline to the end of treatment at 24 weeks
Change in depressive symptoms, as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Measured: From baseline to the end of treatment at 24 weeks
Change in daily moderate-to-vigorous physical activity (MVPA; min/day), as assessed by ActiGraph accelerometry
Measured: From baseline to the end of treatment at 24 weeks
Change in skeletal muscle mass (kg), as assessed by bioelectrical impedance analysis (BIA)
Measured: From baseline to the end of treatment at 24 weeks
Change in fat mass (kg), as assessed by BIA
Measured: From baseline to the end of treatment at 24 weeks
Change in phase angle (°), as assessed by BIA
Measured: From baseline to the end of treatment at 24 weeks
Change in absolute maximal oxygen consumption (mL/min), as assessed by cardiopulmonary exercise testing (CPET)
Measured: From baseline to the end of treatment at 24 weeks
Change in relative maximal oxygen consumption (mL/kg/min), as assessed by CPET
Measured: From baseline to the end of treatment at 24 weeks
Adherence to the IMP, assessed by injection pen counts
Defined as the proportion of prescribed doses administered during the treatment period (%)
Measured: From baseline to the end of treatment at 24 weeks
Highest achieved and maintained (tolerated) dose of tirzepatide during the intervention period
Defined as the highest weekly dose level maintained for ≥4 weeks, allowing up to one missed scheduled administration, without subsequent dose reduction and without permanent discontinuation due to intolerance
Measured: From baseline to the end of treatment at 24 weeks
Adherence to the resistance training intervention (experimental group only), assessed using automatically recorded training data from the exercise devices
Defined as the mean number of completed training sessions per week during the intervention period.
Measured: From baseline to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start7 Oct 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- EGYM SE
- Responsible party
- Sponsor
- Investigators
- Martin Halle, MD, Principal investigator, Klinikum der Technischen Universität München (TUM Klinikum)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777575
- Sponsor's protocol ID
- RESIST-26-HAL-0150-I
- Other IDs
- 2026-526200-69-00
- Acronym
- RESIST
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized Controlled Trial to Evaluate the Effects of Resistance Training Versus Usual Care on Thigh Muscle Volume During Treatment With the Dual GIP/GLP-1 Receptor Agonist Tirzepatide in Adults With Obesity
- ClinicalTrials.gov ID
- NCT07777575
- Acronym / sponsor ID
- RESIST / RESIST-26-HAL-0150-I
- Conditions
- Obesity (BMI>30)
- Keywords
- skeletal muscle, weight loss, exercise training, strength training, incretin-based therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- EGYM SE
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Aug 2026 (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-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'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual GIP/GLP-1 Receptor Agonist Tirzepatide | Active comparator | Drug: Dual GIP/GLP-1 Receptor Agonist Tirzepatide |
| Dual GIP/GLP-1 Receptor Agonist Tirzepatide + Resistance Training | Experimental | Drug: Dual GIP/GLP-1 Receptor Agonist Tirzepatide, Behavioral: Resistance Training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Age
- Are ≥ 18 years and ≤ 60 years of age
- Weight
- 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
Key exclusion criteria (49 listed)
- Medical Conditions Diabetes Related
- 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
- Have at least one laboratory value suggestive of diabetes during screening including:
- Obesity Related
- Have a self-reported reduction in body weight >5 kg within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual GIP/GLP-1 Receptor Agonist TirzepatideTirzepatide 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 | Drug | Dual GIP/GLP-1 Receptor Agonist Tirzepatide, Dual GIP/GLP-1 Receptor Agonist Tirzepatide + Resistance Training |
| Resistance TrainingLow-volume, high-intensity resistance training on 3 days/week | Behavioural | Dual GIP/GLP-1 Receptor Agonist Tirzepatide + Resistance Training |
Primary outcome
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
21 secondary outcomes
Change in body weight (kg), as assessed by a calibrated scale
Time frame: From baseline to the end of treatment at 24 weeks
Change in anterior thigh intramuscular fat fraction (%), as assessed by MRI
Time frame: From baseline to the end of treatment at 24 weeks
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
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
Change in peak isometric knee extension torque (Nm), as assessed using an isokinetic dynamometer
Time frame: From baseline to the end of treatment at 24 weeks
Change in maximum handgrip strength (kg), as assessed by a hand dynamometer
Time frame: From baseline to the end of treatment at 24 weeks
Change in the number of chair stands, as assessed by the 30-second chair stand test
Time frame: From baseline to the end of treatment at 24 weeks
Change in usual gait speed (m/s), as assessed by the time required to walk 10 meters
Time frame: From baseline to the end of treatment at 24 weeks
Change in physical health-related QoL, as assessed by the Physical Component Summary score of the Short-Form-36 Health Survey, Version 2, Acute Form (SF-36v2)
Time frame: From baseline to the end of treatment at 24 weeks
Change in mental health-related QoL, as assessed by the Mental Component Summary score of the SF-36v2
Time frame: From baseline to the end of treatment at 24 weeks
Change in obesity-specific QoL, as assessed by the Total Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Time frame: From baseline to the end of treatment at 24 weeks
Change in depressive symptoms, as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: From baseline to the end of treatment at 24 weeks
Change in daily moderate-to-vigorous physical activity (MVPA; min/day), as assessed by ActiGraph accelerometry
Time frame: From baseline to the end of treatment at 24 weeks
Change in skeletal muscle mass (kg), as assessed by bioelectrical impedance analysis (BIA)
Time frame: From baseline to the end of treatment at 24 weeks
Change in fat mass (kg), as assessed by BIA
Time frame: From baseline to the end of treatment at 24 weeks
Change in phase angle (°), as assessed by BIA
Time frame: From baseline to the end of treatment at 24 weeks
Change in absolute maximal oxygen consumption (mL/min), as assessed by cardiopulmonary exercise testing (CPET)
Time frame: From baseline to the end of treatment at 24 weeks
Change in relative maximal oxygen consumption (mL/kg/min), as assessed by CPET
Time frame: From baseline to the end of treatment at 24 weeks
Adherence to the IMP, assessed by injection pen counts
Time frame: From baseline to the end of treatment at 24 weeks
Highest achieved and maintained (tolerated) dose of tirzepatide during the intervention period
Time frame: From baseline to the end of treatment at 24 weeks
Adherence to the resistance training intervention (experimental group only), assessed using automatically recorded training data from the exercise devices
Time frame: From baseline to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity (BMI>30)
Active, not recruiting
Influence of the Urolithin A on the Population With BMI Higher Than 30 During Restricted Eating.
Obesity & Overweight
Active, not recruiting
Effects of a High-protein Diet and Resistance Training on Fat-mass Loss Maintenance
Obesity (Body Mass Index >30 kg/m2)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Recruiting
Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
Obesity (BMI Equal to or >30), Immune Function
RecruitingObservational study
Frontal EEG Dynamics During Anesthesia in Patients With Obesity and Normal Weight
Obesity (BMI>30), General Anesthesia
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.
Martin Halle, MD principal investigator
Klinikum der Technischen Universität München (TUM Klinikum)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual GIP/GLP-1 Receptor Agonist Tirzepatide and Resistance Training in people with Obesity (BMI>30), run by Technical University of Munich at 1 site in Germany.
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 18 inclusion and 49 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: looking for participants now, as of the sponsor's last update on 20 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Mueller-Stegner, Dr rer nat (+49 (0)89 289-24494, stephan.mueller@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 20 Oct 2026.