NSCLC

RecruitingPhase 1

Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib

Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)

Lead sponsor

University of Chicago

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Oncology

Eligibility highlights

Primary endpoints

•Body weight changes•Lipid changes•Cmax

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07782359

Org study IDIRB25-1926

Timeline

Milestones

Study first posted2026-08-24actual

Study start2026-10-22actual

Last update posted2026-10-27actual

Primary completion2030-06estimated (month precision)

Study completion2030-06estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years

•Receiving lorlatinib as first-line treatment for advanced NSCLC ALK-positive, already prescribed and administered by the patient's treating oncologist as standard of care at the time of study enrollment. This study does not initiate lorlatinib therapy or assign lorlatinib dosing; participants must already be receiving lorlatinib prior to enrollment

Exclusion criteria

•Known hypersensitivity to GLP-1 agonists.

•Active, unstable psychiatric illness; current suicidal ideation

•Severe organ dysfunction or systemic illness.

•Anorexia nervosa

•History of pancreatitis

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

•Current use of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) or glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [GLP-1 RA/GIP] co-agonist use within the last 90 days prior to screening

•Current anti-obesity medication use (other than GLP-1 RA) or dipeptidyl peptidase-4 (DPP4) inhibitor use or use within the last 30 days prior to screening

•Pregnant, breastfeeding or planning pregnancy

Endpoints (9)

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

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Primary/protocol endpoint

Body weight changes

Time frame:1 year post treatment start

descriptive

Secondary/protocol endpoint

Changes in waist circumference

Time frame:1 year from start of treatment

descriptive

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Lipid changes

Time frame:1 year post treatment start

descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Change in Cmax

Time frame:1 year post treatment start

change from baseline, event

Primary/protocol endpoint

Change in Tmax

Time frame:1 year post treatment start

change from baseline, event

Primary/protocol endpoint

Bioavailability

Time frame:1 year post treatment start

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Rate of metabolic side effects

Time frame:1 year from start of treatment

descriptive

Secondary/protocol endpoint/low confidence

Changes in body mass composition

Time frame:1 year from start of treatment

descriptive

Secondary/protocol endpoint/low confidence

Changes in cardiometabolic markers

Time frame:1 year from start of treatment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.