ClinicalTrials.gg
Not yet recruitingNCT07931196RESIST-EXPLOREUpdated Nov 12, 2026

Molecular and Microbiome Changes During Tirzepatide Treatment and Resistance Training in Obesity

An observational study in Obesity (BMI Equal to or >30), sponsored by Technical University of Munich. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Technical University of Munich · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Obesity by Technical University of Munich — 4 open to participants now, 4 under way, none of them phase 3. Obesity · Technical University of Munich.

Started
2026
with 3 others
Observational
4 of 10
3 open now
Registered
8th of 10
by date

Among the 10 studies in Obesity by Technical University of Munich, this one is one of 4 that started in 2026, is one of 4 observational ones, and was the 8th registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

Browse Obesity studies →

Open to participants now

4 of the 10 studies in Obesity by Technical University of Munich are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Obesity by Technical University of Munich, or all of them as a file.
02

Study summary

This study is an ancillary study to the RESIST trial, in which adults with obesity receive the weight-loss medication tirzepatide and are randomly assigned to a structured resistance training program or to usual care for 24 weeks. RESIST-EXPLORE investigates which molecular, metabolic, inflammatory, immune-cell and microbiome-related changes occur during this treatment, and how they relate to changes in body weight, body composition and muscle-related outcomes measured in RESIST. Blood samples are collected at the start (Week 0) and at the end (Week 24) of treatment; stool samples and tongue and nasal swabs are collected at Week 0, Week 4 and Week 24.

Read the detailed description

RESIST-EXPLORE is a prospective, observational, monocentric ancillary study to the RESIST trial conducted at the TUM Klinikum, Munich, Germany, in collaboration with Helmholtz Munich. Active participation in the RESIST trial (protocol code RESIST-26-HAL-0150-I; EU CT number 2026-526200-69-00) is a prerequisite for enrolment. RESIST is a randomized, controlled, open-label Phase IV trial evaluating a structured resistance training program versus usual care in 150 adults with obesity treated with tirzepatide (Mounjaro®) over 24 weeks.

RESIST-EXPLORE aims to characterize treatment-associated changes in molecular, metabolic, inflammatory, immune-cell, and microbiome profiles, and to examine their associations with changes in body weight, body composition, and muscle-related outcomes. All analyses are exploratory.

RESIST-EXPLORE involves no investigational medicinal product, no intervention and no randomization. Assignment to resistance training or usual care occurs exclusively within the RESIST trial. In RESIST-EXPLORE, biosamples are collected at RESIST visits: blood (plasma, serum, circulating immune cells) at baseline (V1, Week 0) and end of treatment (V7, Week 24); stool samples (self-collected at home) and tongue and nasal swabs at V1, V2 (Week 4) and V7. Short questionnaires on factors relevant to microbiome analyses (e.g., antibiotic use, diet, stool consistency, oral and nasal health) are completed at each microbiome sampling time point.

Planned analyses include proteomic and other biomarker analyses of plasma and serum; immune cell profiling by flow cytometry, functional immune assays and transcriptomic analyses including single-cell RNA sequencing; and characterization of the intestinal, oral and nasal microbiome by 16S rRNA sequencing and shotgun metagenomics, including microbial metabolites such as short-chain fatty acids and volatile organic compounds. Biosample-derived data are linked with clinical data from the RESIST trial.

03

Conditions studied

  • Obesity (BMI Equal to or >30)

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants of the RESIST trial at the TUM Klinikum, Munich: adults aged 18-60 years with obesity (BMI ≥ 30 kg/m²) without manifest type 2 diabetes or structural cardiovascular disease, eligible for pharmacological weight-loss therapy and suitable for a structured resistance training program. Sufficient command of German is required

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

  • Provisional eligibility for randomization into the RESIST trial (based on all RESIST screening assessments available at the time of for this ancillary study)
  • Written informed consent for this ancillary study

Exclusion criteria

Exclusion Criteria:

  • Non-randomization into the RESIST trial for any reason

Key eligibility criteria of the RESIST trial (for context only; full criteria see RESIST protocol RESIST-26-HAL-0150-I):

  • Age 18-60 years
  • Obesity ( ≥ 30 kg/m²)
  • No manifest type 2 diabetes
  • No structural cardiovascular disease
  • Not pregnant or breastfeeding
  • Sufficient command of the German language
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Resistance training + tirzepatide

    RESIST participants randomized to the structured resistance training arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study.

    Behavioral: Structured resistance training · Drug: Tirzepatide

  • Usual care + tirzepatide

    RESIST participants randomized to the usual care arm of the RESIST trial, receiving tirzepatide and individualized diet and physical activity counselling. Assignment occurs within RESIST, not within this ancillary study.

    Drug: Tirzepatide

Interventions

  • BehavioralStructured resistance training

    Machine-based structured resistance training over 24 weeks (72 sessions, approx. 3 sessions per week), delivered within the RESIST trial (not part of this ancillary study). Progressive program with an acclimation phase (weeks 1-4) and a target phase (weeks 5-24; 8-12 repetitions at approx. 70-75% 1-RM, with additional eccentric overload from week 9). Sessions are fully supervised during the first 6 weeks whenever feasible, thereafter at least one supervised session after each interim visit; remaining sessions at the trial site or at partner fitness facilities.

  • Once-weekly subcutaneous injection over 24 weeks, starting at 2.5 mg/week and increased by 2.5 mg every 4 weeks as tolerated up to a maximum of 10 mg/week, in accordance with the SmPC. Administered within the RESIST trial (not part of this ancillary study).

06

What researchers measure

Primary outcomes

  1. Change in circulating protein biomarker profile (plasma/serum)

    Circulating proteins related to inflammation, metabolism and cardiovascular health measured by high-throughput proteomics (e.g., Olink®).

    Time frame: Baseline (Week 0) and end of treatment (Week 24)

  2. Change in frequencies of circulating lymphocyte subsets

    Frequencies of circulating lymphocyte subsets, including subsets defined by markers of activation, senescence and exhaustion, measured by multiparameter flow cytometry and expressed as percentage of the respective parent population.

    Time frame: Baseline (Week 0) and end of treatment (Week 24)

  3. Change in gut microbiome composition and diversity (stool)

    Microbial composition and diversity determined by 16S rRNA sequencing and shotgun metagenomics.

    Time frame: Baseline (Week 0), Week 4 and end of treatment (Week 24)

  4. Change in oral microbiome composition and diversity (tongue swab)

    Microbial composition and diversity determined by 16S rRNA sequencing and shotgun metagenomics.

    Time frame: Baseline (Week 0), Week 4 and end of treatment (Week 24)

  5. Change in nasal microbiome composition and diversity (nasal swab)

    Microbial composition and diversity determined by 16S rRNA sequencing and shotgun metagenomics.

    Time frame: Baseline (Week 0), Week 4 and end of treatment (Week 24)

Secondary outcomes

  1. Change in functional immune responses

    T-cell receptor-mediated activation and inflammasome assays, including assays using participant serum.

    Time frame: Baseline (Week 0) and end of treatment (Week 24)

  2. Change in immune cell transcriptome

    Transcriptomic analyses of isolated immune cells, including single-cell RNA sequencing

    Time frame: Baseline (Week 0) and end of treatment (Week 24)

  3. Change in microbial metabolites

    Short-chain fatty acids and volatile organic compounds

    Time frame: Baseline (Week 0), Week 4 and end of treatment (Week 24)

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

Individual participant data

Plan to share: No — Individual participant data will not be made publicly available due to privacy restrictions. Pseudonymized data and biosamples are shared only with research partners and service providers to the extent required for the analyses defined in the protocol, under appropriate data or material transfer agreements.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.

Of 792 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 8 months is below that.

Counting every sponsor, half of 837 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2026
First posted
Nov 12, 2026
StartEst.
Oct 22, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

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
NCT07931196
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Oct 22, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Prof. Dr. med. Martin Halle
Contact
resist@mri.tum.de
+49.89.289.244.29
Sophia M Dinges, M.Sc.
Contact
Sophia.Dinges@mri.tum.de
+49.89.289.24494
Martin Halle, Prof. Dr. med.
principal investigator · TUM Klinikum, Department for Preventive Sports Medicine and Sports Cardiology
Katharina Timper, Prof. Dr. med.
principal investigator · TUM Klinikum, Department for Clinical Nutritional Medicine
Susanna M Hofmann, Prof. Dr. med.
principal investigator · Helmholtz Center Munich - German Research Center for Environmental Health, Institute for Diabetes and Regeneration, Research Group "Women and Diabetes"

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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