Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma | NCT07713901

NCT07713901

Overview

NCT ID: NCT07713901
Lead Sponsor: Novo Nordisk A/SINDUSTRY
Official Title: Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma
Brief Summary: This is a database linkage study utilizing real-world data (RWD) to determine whether certain medicines used to treat type 2 diabetes (T2D) and support weight management (called GLP-1 RAs (Glucagon-like peptide-1 receptor agonists )) are linked to an increased risk of a rare cancer called medullary thyroid carcinoma (MTC). The purpose of this study is to compare how often medullary thyroid cancer occurs in people taking these medicines versus those taking other similar treatments. This study will use dispensed prescription claims and State Cancer Registry data to assess the risk of MTC.
Conditions: Medullary Thyroid Carcinoma

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 20, 2026Actual
Start Date: Dec 31, 2025Actual
Primary Completion Date: Dec 31, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

18 years or older during the year of index (date of qualifying medication)

In addition to index medication, greater than or equal to (≥) 1 dispensed medication (any class) within 24 months prior to the index date1

≥1 dispensed medication (any class) after the index date and within 12 months of index date (12-month post-index period)

No evidence of cohort qualifying medication during 12-month before the index date

Reside in the US, including the District of Columbia (DC) during the study period

No missing values for year of birth

Exclusion Criteria:

Patients with a diagnosis of MTC in the linked SCR data before their index date will not be included in the study.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 93,600,000Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: IQVIA

Similar Studies

Participant Group/Arms

Long-acting GLP-1 RA Exposed Cohort

Participants will be eligible for inclusion in this cohort if they have at least one dispensed prescription for a LA GLP-1 RA therapy during the study patient selection period.

Other: No treatment given

T2D Active Comparator 1 Cohort

Participants will be included in this cohort if they fill at least one dispensed prescription for SGLT2 or DPP-4 inhibitors during the study patient selection period with no evidence of SGLT2 or DPP-4 inhibitors and without LA GLP-1 RA use during the prior 12-month lookback period.

Other: No treatment given

T2D Active Comparator 2 Cohort

Participants will be included in this cohort if they fill at least one dispensed prescription for any antidiabetic medications (including SGLT2 or DPP-4 inhibitors), other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.

Other: No treatment given

Overweight/Obesity Active Comparator Cohort

Participants will be included in this cohort if they fill at least one dispensed prescription for anti-obesity medications, other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.

Other: No treatment given