Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma

Part of paid clinical trials in Parsippany, New Jersey.

Sponsor
Novo Nordisk A/S
Study ID
NCT07713901
Status
Enrolling By Invitation

Conditions

  • Medullary Thyroid Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No treatment given — OTHER
    No treatment given

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Dec 31, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
93,600,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Time to first occurence of Medullary Thyroid Carcinoma (MTC) [ Time Frame: From day 1 up to 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
IQVIAParsippanyNew Jersey07054-

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