臨床研究等提出・公開システム

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight
(I8F-MC-GPJA )

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
(I8F-MC-GPJA)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

May. 20, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Have type 1 diabetes and on insulin treatment for at least one year prior to screening
- Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
- Have a body mass index (BMI) of >=25 kilograms per square meter (kg/m2) at screening
- Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study

- Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
- Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have had chronic or acute pancreatitis
- Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Both

Type 1 Diabetes
Obesity
Overweight

DRUG: Tirzepatide(Other Name: LY3298176)
Administered SC
DRUG: Placebo
Administered SC

(Study Arms)
Experimental: Tirzepatide Dose 1
Participants will receive tirzepatide subcutaneously (SC)
Interventions:
Drug: Tirzepatide
Experimental: Tirzepatide Dose 2
Participants will receive tirzepatide SC
Interventions:
Drug: Tirzepatide
Experimental: Tirzepatide Dose 3
Participants will receive tirzepatide SC
Interventions:
Drug: Tirzepatide
Experimental: Tirzepatide Dose 4
Participants will receive tirzepatide SC
Interventions:
Drug: Tirzepatide
Placebo Comparator: Placebo
Participants will receive placebo SC
Interventions:
Drug: Placebo

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40

Feb. 28, 2025

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States/Argentina/Brazil/Denmark/France/Germany/Israel/Italy/Mexico/Puerto Rico/Spain