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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250060
Enrollment
905
Registered
2025-04-28
Start date
2025-05-20
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Obesity Overweight

Interventions

DRUG: Tirzepatide(Other Name: LY3298176) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Tirzepatide Dose 1 Participants will receive tirzepatide subcutaneously (SC)

Sponsors

Masaki Takeshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

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

Countries

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

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026