A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03322631

I8F-JE-GPGC (Other Identifier)

16400

Details and patient eligibility

About

The purposes of this study are to determine:

• The safety of tirzepatide and any side effects that might be associated with it.
• How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
• How tirzepatide affects the levels of blood sugar.

This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.

Enrollment: 48 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)
• Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

Exclusion criteria

• Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
• Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
• Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received placebo administered into the SC tissue of the abdominal wall.

Treatment:

Drug: Placebo