NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 3

Sponsor: Eli Lilly and Company

Conditions: Type 2 Diabetes

Interventions: Orforglipron

Countries: Japan

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 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (40)

Nagoya, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Kashiwa, Chiba, Japan
Mihama-ku,Chiba City, Chiba, Japan
Matsuyama, Ehime, Japan
Kitakyushu, Fukuoka, Japan
Chitose, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Mito, Ibaraki, Japan
Mito, Ibaraki, Japan
Naka, Ibaraki, Japan
Naka, Ibaraki, Japan
Tsuchiura, Ibaraki, Japan
Kamakura, Kanagawa, Japan
Kamakura-shi, Kanagawa, Japan
Yamato-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokkaichi, Mie-ken, Japan
Matsumoto, Nagano, Japan
Kashihara, Osaka, Japan
Osaka, Osaka, Japan
Suita-shi, Osaka, Japan
Kawaguchi, Saitama, Japan
Sōka, Saitama, Japan
Adachi-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Hachioji-shi, Tokyo, Japan
+ 10 more on CT.gov