Lung CancerPhase 1NSCLCNCT07782359
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
A Phase 1 study testing Tirzepatide in people with Lung Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2026to Jun 2030
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
About this study
Official title: Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)
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
- Being tested
- Tirzepatide
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Monjouro, Zepbound
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.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide Treatment | Experimental | 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes
To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
Measured: 1 year post treatment start
Lipid changes
To assess the effect of tirzepatide on change in lipid profile High-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides) at 52 weeks compared to baseline.
Measured: 1 year post treatment start
Change in Cmax
Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.
Measured: 1 year post treatment start
Change in Tmax
Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.
Measured: 1 year post treatment start
Bioavailability
Evaluate partial AUC to estimate the extent of drug absorption.
Measured: 1 year post treatment start
Secondary outcomes (4)
Rate of metabolic side effects
Number of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1-3 metabolic side effects
Measured: 1 year from start of treatment
Changes in body mass composition
Changes in body mass will be measured using Bioelectrical Impedance Analysis (BIA).
Measured: 1 year from start of treatment
Changes in waist circumference
Measured: 1 year from start of treatment
Changes in cardiometabolic markers
The number of participants that experience a change in cardiometabolic markers will be reported. This includes changes in blood tests for any of the following: Hemoglobin A1c (HbA1c), insulin, glucose, Apolipoprotein B (ApoB), homocysteine, C-reactive protein (CRP), and lipoprotein(a) (Lp(a))
Measured: 1 year from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start22 Oct 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Marina Garassino, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782359
- Sponsor's protocol ID
- IRB25-1926
- Acronym
- NSCLC
- Status last verified
- Oct 2026
- First submitted
- 7 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07782359
- Acronym / sponsor ID
- NSCLC / IRB25-1926
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 24 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide Treatment | Experimental | Drug: TirzepatideIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Known hypersensitivity to GLP-1 agonists.
- Active, unstable psychiatric illness; current suicidal ideation
- Severe organ dysfunction or systemic illness.
- Anorexia nervosa
- History of pancreatitis
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 |
|---|---|---|
| TirzepatideAlso: Monjouro, ZepboundParticipants 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. | Drug | Tirzepatide Treatment |
Primary outcome
Body weight changes
Time frame: 1 year post treatment start
To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
Lipid changes
Time frame: 1 year post treatment start
To assess the effect of tirzepatide on change in lipid profile High-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides) at 52 weeks compared to baseline.
Change in Cmax
Time frame: 1 year post treatment start
Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.
Change in Tmax
Time frame: 1 year post treatment start
Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.
Bioavailability
Time frame: 1 year post treatment start
Evaluate partial AUC to estimate the extent of drug absorption.
4 secondary outcomes
Rate of metabolic side effects
Time frame: 1 year from start of treatment
Changes in body mass composition
Time frame: 1 year from start of treatment
Changes in waist circumference
Time frame: 1 year from start of treatment
Changes in cardiometabolic markers
Time frame: 1 year from start of treatment
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 27 Oct 2026.
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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.
Marina Garassino principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tirzepatide in people with Lung Cancer, run by University of Chicago at 1 site in United States.
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 2 inclusion and 9 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 27 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Trials Intake Intake (855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changes (time frame: 1 year post treatment start). The study lists 5 primary outcomes in all. 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 27 Oct 2026.