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Obesity & OverweightNCT07513259

Pre-Diagnosis GLP-1 Receptor Agonist Use and Post-Cancer Mortality in Adults With Obesity and Type 2 Diabetes

An observational study of Obesity & Overweight and Diabetes Mellitus Type 2, run by Chung Shan Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine whether the type of diabetes treatment used before cancer diagnosis is associated with survival and serious complications after obesity-associated cancer in adults with obesity and type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
How many people
203,424 participants
Where
1 siteTaiwan
Study dates
1 Jan 2018to 31 Oct 2025
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Study population: Adults will be selected from the TriNetX US Collaborative Network, a distributed database of de-identified electronic health records contributed by participating healthcare organizations across multiple clinical systems and practice settings. The study population consists of adults with obesity and type 2 diabetes who received routine clinical care in this network and were identified through diagnosis records, body mass index data, and medication prescribing data. The overall study population was classified into two mutually exclusive cohorts according to pre-diagnosis GLP-1 receptor agonist use: participants with pre-diagnosis GLP-1 receptor agonist use and participants without pre-diagnosis GLP-1 receptor agonist use. Comparator-specific propensity score-matched cohorts for GLP-1 RA versus SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas, metformin, and usual care were defined within this source population for prespecified pairwise outcome analyses.

Who may be able to join

  • Adults aged 18 years or older
  • BMI ≥27 kg/m2, or diagnosis codes consistent with obesity
  • Type 2 diabetes mellitus
  • Initiation of a glucose-lowering medication before obesity-associated cancer diagnosis
  • Incident obesity-associated cancer diagnosed after medication initiation
  • No dispensing of the study drug class during the 6-month washout period before the first qualifying prescription

Who cannot join

  • Type 1 diabetes mellitus, Other specified diabetes types that are not type 2 diabetes
  • Human immunodeficiency virus infection
  • End-stage renal disease
  • Prior bariatric surgery
  • Prior organ transplantation
  • Transplant-related complications
  • Any use of tirzepatide before cohort entry

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chung Shan Medical University Hospital

    Taichung, Taichung City, 402

Other trials in Taiwan

About this study

Official title: Pre-Diagnosis GLP-1 Receptor Agonist Use and Post-Cancer Mortality in Adults With Obesity and Type 2 Diabetes: A Target Trial Emulation

This study will examine whether the type of diabetes treatment used before cancer diagnosis is associated with survival and serious complications after obesity-associated cancer in adults with obesity and type 2 diabetes. The study focuses on glucagon-like peptide-1 receptor agonists (GLP-1 RA) and compares them with other commonly used glucose-lowering therapies, including SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas, metformin, and usual care. Using de-identified electronic health record data from the TriNetX US Collaborative Network, the study will assess whether patients who used GLP-1 RA before cancer diagnosis have different risks of death, hospitalization, sepsis, and other major outcomes after cancer diagnosis. This is an observational study designed to evaluate associations in routine clinical care and not to prove a treatment effect.

Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07513259
Study groupRoleWhat they receive
GLP-1 RAAdults with obesity and type 2 diabetes who developed an obesity-associated cancer after initiating a GLP-1 receptor agonist before cancer diagnosis. This cohort served as the GLP-1 RA exposure cohort in the overall study population and represents the unique participants with pre-diagnosis GLP-1 receptor agonist use.
Usual Care Without GLP-1 RAAdults with obesity and type 2 diabetes who developed an obesity-associated cancer and had no GLP-1 receptor agonist prescriptions before cancer diagnosis. This cohort served as the non-GLP-1 RA comparator cohort in the overall study population. Participants could receive routine clinical care, including other non-GLP-1 RA glucose-lowering medications. This cohort represents the unique participants without pre-diagnosis GLP-1 receptor agonist use.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality (Comparison 1)

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  2. All-cause Mortality (Comparison 2)

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  3. All-cause Mortality (Comparison 3)

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  4. All-cause Mortality (Comparison 4)

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  5. All-cause Mortality (Comparison 5)

    All-cause mortality within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

    Measured: From obesity-associated cancer diagnosis through 36 months

Secondary outcomes (20)
  1. Inpatient (Comparison 1)

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  2. Inpatient (Comparison 2)

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  3. Inpatient (Comparison 3)

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  4. Inpatient (Comparison 4)

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  5. Inpatient (Comparison 5)

    Inpatient within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

    Measured: From obesity-associated cancer diagnosis through 36 months

  6. Pericardial Effusion (Comparison 1)

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  7. Pericardial Effusion (Comparison 2)

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  8. Pericardial Effusion (Comparison 3)

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  9. Pericardial Effusion (Comparison 4)

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  10. Pericardial Effusion (Comparison 5)

    Pericardial effusion within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

    Measured: From obesity-associated cancer diagnosis through 36 months

  11. Pulmonary Embolism (Comparison 1)

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  12. Pulmonary Embolism (Comparison 2)

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  13. Pulmonary Embolism (Comparison 3)

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  14. Pulmonary Embolism (Comparison 4)

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  15. Pulmonary Embolism (Comparison 5)

    Pulmonary embolism within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

    Measured: From obesity-associated cancer diagnosis through 36 months

  16. Sepsis (Comparison 1)

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 1, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior SGLT2 inhibitor use versus SGLT2 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  17. Sepsis (Comparison 2)

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 2, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior DPP-4 inhibitor use versus DPP-4 inhibitor-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  18. Sepsis (Comparison 3)

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 3, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior sulfonylurea use versus sulfonylurea-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  19. Sepsis (Comparison 4)

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 4, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist without prior metformin use versus metformin-treated adults.

    Measured: From obesity-associated cancer diagnosis through 36 months

  20. Sepsis (Comparison 5)

    Sepsis within 36 months after obesity-associated cancer diagnosis in the propensity score-matched cohort for Comparison 5, comparing adults with obesity and type 2 diabetes treated with GLP-1 receptor agonist versus adults receiving usual care.

    Measured: From obesity-associated cancer diagnosis through 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 Jan 2018
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
203,424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513259
Sponsor's protocol ID
CS2-24004
Status last verified
Jun 2026
First submitted
31 Mar 2026
Last updated
17 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. This retrospective observational study uses de-identified electronic health record data from the TriNetX US Collaborative Network. Access to individual-level data is restricted by data use agreements, institutional policies, and privacy protections. Researchers who meet eligibility requirements may obtain access to similar de-identified data through a TriNetX license or through participating institutions.

Publications

  • Kim C, Dinan MA, Robinson TJ, Ross JS, Jastreboff AM, Krumholz HM, Lu Y. Semaglutide and Tirzepatide Prescribing for Obesity in Patients With Preexisting Comorbid Cancers. JAMA Oncol. 2025 Nov 6;12(1):101-4. doi: 10.1001/jamaoncol.2025.4560. Online ahead of print.

    PubMed 41196576
  • Tsujimoto T, Kajio H, Sugiyama T. Association between hyperinsulinemia and increased risk of cancer death in nonobese and obese people: A population-based observational study. Int J Cancer. 2017 Jul 1;141(1):102-111. doi: 10.1002/ijc.30729. Epub 2017 Apr 22.

    PubMed 28390156
  • Zhang AMY, Wellberg EA, Kopp JL, Johnson JD. Hyperinsulinemia in Obesity, Inflammation, and Cancer. Diabetes Metab J. 2021 May;45(3):285-311. doi: 10.4093/dmj.2020.0250. Epub 2021 Mar 29.

    PubMed 33775061
  • Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24.

    PubMed 38785209
  • Wong CK, McLean BA, Baggio LL, Koehler JA, Hammoud R, Rittig N, Yabut JM, Seeley RJ, Brown TJ, Drucker DJ. Central glucagon-like peptide 1 receptor activation inhibits Toll-like receptor agonist-induced inflammation. Cell Metab. 2024 Jan 2;36(1):130-143.e5. doi: 10.1016/j.cmet.2023.11.009. Epub 2023 Dec 18.

    PubMed 38113888
  • Rohm TV, Meier DT, Olefsky JM, Donath MY. Inflammation in obesity, diabetes, and related disorders. Immunity. 2022 Jan 11;55(1):31-55. doi: 10.1016/j.immuni.2021.12.013.

    PubMed 35021057
  • Wong CK, Drucker DJ. Antiinflammatory actions of glucagon-like peptide-1-based therapies beyond metabolic benefits. J Clin Invest. 2025 Nov 3;135(21):e194751. doi: 10.1172/JCI194751. eCollection 2025 Nov 3.

    PubMed 41178710
  • Zheng Z, Zong Y, Ma Y, Tian Y, Pang Y, Zhang C, Gao J. Glucagon-like peptide-1 receptor: mechanisms and advances in therapy. Signal Transduct Target Ther. 2024 Sep 18;9(1):234. doi: 10.1038/s41392-024-01931-z.

    PubMed 39289339
  • Chen B, Yu X, Horvath-Diano C, Ortuno MJ, Tschop MH, Jastreboff AM, Schneeberger M. GLP-1 programs the neurovascular landscape. Cell Metab. 2024 Oct 1;36(10):2173-2189. doi: 10.1016/j.cmet.2024.09.003.

    PubMed 39357509
  • Pfaffenlehner M, Behrens M, Zoller D, Ungethum K, Gunther K, Rucker V, Reese JP, Heuschmann P, Kesselmeier M, Remo F, Scherag A, Binder H, Binder N; EVA4MII project. Methodological challenges using routine clinical care data for real-world evidence: a rapid review utilizing a systematic literature search and focus group discussion. BMC Med Res Methodol. 2025 Jan 14;25(1):8. doi: 10.1186/s12874-024-02440-x.

    PubMed 39810151
  • Zhou L, Duanmu W, Tan F, Gu X, Che H, Yin W. Information pharmacists assist in the construction of GLP-1RA prescription review rules in a tertiary hospital in China. BMC Health Serv Res. 2025 Oct 1;25(1):1276. doi: 10.1186/s12913-025-13377-2.

    PubMed 41034888
  • Arroyo V, Angeli P, Moreau R, Jalan R, Claria J, Trebicka J, Fernandez J, Gustot T, Caraceni P, Bernardi M; investigators from the EASL-CLIF Consortium, Grifols Chair and European Foundation for the Study of Chronic Liver Failure (EF-Clif). The systemic inflammation hypothesis: Towards a new paradigm of acute decompensation and multiorgan failure in cirrhosis. J Hepatol. 2021 Mar;74(3):670-685. doi: 10.1016/j.jhep.2020.11.048. Epub 2020 Dec 7.

    PubMed 33301825
  • Liu C, Liu T, Zhang Q, Song M, Zhang Q, Shi J, Deng L, Chen Y, Zheng X, Lin S, Wang Z, Xie H, Chen S, Wu S, Shi H. Temporal relationship between inflammation and metabolic disorders and their impact on cancer risk. J Glob Health. 2024 Feb 16;14:04041. doi: 10.7189/jogh.14.04041.

    PubMed 38386717
  • Silverii GA, Marinelli C, Bettarini C, Del Vescovo GG, Monami M, Mannucci E. GLP-1 receptor agonists and the risk for cancer: A meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2025 Aug;27(8):4454-4468. doi: 10.1111/dom.16489. Epub 2025 May 29.

    PubMed 40437949
  • Valencia-Rincon E, Rai R, Chandra V, Wellberg EA. GLP-1 receptor agonists and cancer: current clinical evidence and translational opportunities for preclinical research. J Clin Invest. 2025 Nov 3;135(21):e194743. doi: 10.1172/JCI194743. eCollection 2025 Nov 3.

    PubMed 41178720

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity & Overweight and Diabetes Mellitus Type 2, run by Chung Shan Medical University at 1 site in Taiwan.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 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 Taiwan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (Comparison 1) (time frame: From obesity-associated cancer diagnosis through 36 months). 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?

On the ClinicalTrials.gov record for NCT07513259, which also lists 38 linked publications.

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 17 Aug 2026.

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