Recruiting
Phase 1

Lorlatinib with Tirzepatide

Sponsor:

University of Chicago

Code:

NCT07782359

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement. This study seeks to evaluate its potential to mitigate side effects while preserving the therapeutic efficacy of lorlatinib.

Conditions

Lung Cancer

Study ID

NCT07782359

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide Treatment

Individuals taking with an body mass index (BMI) in obese range (BMI greater than or equal to 30) or those with a BMI greater than or equal to 27 and with cardiac risk factors will receive tirzepatide starting after study enrollment.

Individuals that do not meet these BMI criteria will start tirzepatide if they experience weight gain of 5% of more during the study.

Statistical analysis will include all participants that receive tirzepatide on this study.

Interventions

Tirzepatide

Participants will receive tirzepatide with weekly subcutaneous injections at 2.5 mg, following a structured dose escalation protocol over 20 weeks to reach the target dose of 15 mg per week or the maximum tolerated dose.

Primary outcome measure

  • Body weight changes [ Time Frame: 1 year post treatment start ]
  • Lipid changes [ Time Frame: 1 year post treatment start ]
  • Change in Cmax [ Time Frame: 1 year post treatment start ]
  • Change in Tmax [ Time Frame: 1 year post treatment start ]
  • Bioavailability [ Time Frame: 1 year post treatment start ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.