DelfaGLP-1 Atlas

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FLEX

RecruitingPhase NA

Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment

Effect of a Progressive Resistance Exercise Program on Muscle Mass and Physical Function During a Tirzepatide Induced Weight Loss in Overweight and Obese Females: a Randomised Parallel Group Study

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI 30-35•Female

Primary endpoints

•Lean mass•Muscle Thickness (Ultrasound)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07457437
Org study ID11468874

Timeline

Milestones

Study first posted2026-03-09actual
Last update posted2026-03-27actual
Study start2026-04-01estimated
Primary completion2027-12-01estimated
Study completion2027-12-01estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age25 Years
Maximum age50 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

•25-50 years old
•BMI ≥27 kg/m2 with one obesity related co-morbidity or a BMI between ≥30 and 35 kg/m2
•Female

Exclusion criteria

•Previous GLP-1RA use
•Diabetes (Type 1 and 2)
•Contraindicative health condition to GLP-1/GIP
•Fail clinically administered health screening form for tirzepatide prescription
•Pregnant or wanting to become pregnant in the next 6 months
•Has or has previously had an eating disorder
•Inability to perform exercise program and exercise tests
•Advised not to exercise by their general practitioner or medical professional
•Current or recent injury within the last 6 months that may affect the ability to carry out resistance exercise
•Has consistently resistance trained previously (>10 sessions per year)
•Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months
•Current or recent, ≤6 months, smoker
•Currently on HRT

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
6
Other clinical outcomes
6
Patient-reported / QoL
3
Other (unclassified)
2
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Skeletal Muscle Mass

Time frame:Skeletal muscle mass will be plotted over time and we will compare the pre , mid and post values (weeks 0, 10 and 20) to see if there was a change in both groups.

Lean mass

change from baseline, improvement

Primary/protocol endpoint

Muscle Thickness (Ultrasound)

Time frame:Muscle thickness in millimetres will be plotted over time (week 0, 4, 8, 10, 12, 16, 20) and compared between the two groups. Muscle thickness will also be measure at two separate time points during a follow up study at week 40 and 72 weeks from week 0.

descriptive

Secondary/protocol endpoint/low confidence

Isokinetic dynamometry (Bicep and Quadriceps) Peak Torque (Nm/kg)

Time frame:Peak torque in Nm/kg will be compared between pre, mid and post (weeks 0, 10 and 20) in both groups and plotted against time. As well as during follow ups at weeks 40 and 72

change from baseline, improvement

Secondary/protocol endpoint

Body Mass (kg)

Time frame:Body mass will be taken weekly and reported to the researchers by participants for weeks 0-20. It will then also be taken at the follow up visits at weeks 40 and 72.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Height (cm)

Time frame:The measure will be taken at the commencement of the study at week 0 during the baseline visit.

descriptive

Secondary/protocol endpoint

Body Composition

Time frame:Fat and lean mass will also be measure every 4 weeks and also be measure at two separate time points during a follow up study at week 40 and 72 weeks from week 0.

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Hba1c

Time frame:Blood samples will be taken at weeks 0,4,8,10,12,16 and 20 as well as the follow up visits at weeks 40 and 72

descriptive

LOINC 4548-4

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Gastrointestinal Symptom Rating Scale Questionnaire (GSRS)

Time frame:The GSRS will be completed remotely from week 0-20 to assess GI symptoms and act as a monitoring tool of participants

descriptive, improvement

Other/protocol endpoint

Quality of Life Short Form 36

Time frame:The SF-36 will be completed remotely on weeks 0, 10 and 20.

SF-36 total

descriptive, improvement

Other/protocol endpoint

The Pittsburgh Sleep Quality Index (PSQI)

Time frame:The PSQI will be completed remotely on weeks 0, 10 and 20.

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Plasma Tirzepatide

Time frame:Blood samples will be taken at weeks 0,4,8,10,12,16 and 20.

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

6 endpoints
Secondary/protocol endpoint

Isokinetic Dynamometry (Quadriceps and Bicep) Fatigue Profile (%)

Time frame:Fatigue profile (%) will be compared between pre, mid and post (weeks 0, 10 and 20) in both groups and plotted against time. As well as during follow ups at weeks 40 and 72

descriptive

Secondary/protocol endpoint

Physical Function 60 second sit-to-stand test

Time frame:Sit to stand scores will be compared between groups and pre, mid and post intervention (weeks 0, 10 and 20). The measured again at follow up visits in week 40 and 72.

descriptive, improvement

Secondary/protocol endpoint/low confidence

Dynamic Balance, Y-balance Test

Time frame:Balance test scores will be compared between groups and at pre, mid and post intervention (weeks 0, 10 and 20). Then again at follow up visits at weeks 40 and 72.

descriptive

Secondary/protocol endpoint

Handgrip dynamometry

Time frame:Grip strength scores will be compared between groups and pre, mid and post intervention (weeks 0, 10 and 20). Then again at follow up visits at weeks 40 and 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Estradiol-β17

Time frame:Serum estradiol-β17 will be measured at baseline (week 0)

Androgen, change

descriptive

Secondary/protocol endpoint/low confidence

Progesterone

Time frame:Serum progesterone will be measured at baseline (Week 0)

Androgen, change

descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Habitual physical activity (MET)

Time frame:Physical activity will be measured on week 0, 10 and 20.

descriptive

Other/protocol endpoint/low confidence

Basal Metabolic Rate (BMR)

Time frame:Basal metabolic rate will be measured on week 0 and 20. Then during the follow up visits at week 40 and 72.

change from baseline, descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.