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COMPLETEDPhase 3NCT06010004

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 ...

Lead sponsor: Eli Lilly and Company•40 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Eli Lilly and Company

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Have Type 2 Diabetes (T2D)
•Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
•Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
•Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria

•Have Type 1 Diabetes (T1D).
•Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
•Have New York Heart Association functional classification IV congestive heart failure.
•Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
•* acute myocardial infarction
•* cerebrovascular accident (stroke), or
•* hospitalization for congestive heart failure
•Have acute or chronic hepatitis and pancreatitis

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 14, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment466

Start dateSep 2023

Last updatedJul 14, 2025

Condition

Type 2 Diabetes

Locations shown

Nakayama Clinic

Nagoya, Aichi-ken

Shinkashiwa Clinic

Kashiwa, Chiba

Kashiwa City Hospital

Kashiwa, Chiba

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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