臨床研究等提出・公開システム

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination with Tirzepatide, in Japanese Participants with Obesity or Overweight (J3R-JE-YDAB)

A Study of LY3841136 in Japanese Participants With Obesity or Overweight (J3R-JE-YDAB)

Wakayama Naohiko

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

Not Recruiting

April. 05, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Male or female participants who agree to contraception requirements
Have a body mass index (BMI) within the range of 27 to 40 kg/m2, inclusive
Have had a stable weight for the 3 months

Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
Have a history of chronic medical conditions involving the heart, liver, or kidneys
Have a history of any malignancy within the past 5 years
Have a history or presence of a GI disorder
Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
For participants in Part B, have previously received tirzepatide within 6 months prior to screening
For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2

Both

Obesity
Overweight

DRUG: LY3841136
Administered SC
DRUG: LY3841136-Placebo
Administered SC
DRUG: Tirzepatide
Administered SC
DRUG: Tirzepatide-Placebo
Administered SC

Experimental: Part A: LY3841136
LY3841136 administered subcutaneously (SC)
Interventions:
Drug: LY3841136
Placebo Comparator: Part A: Placebo
Placebo administered SC
Interventions:
Drug: LY3841136-Placebo
Experimental: Part B: Tirzepatide + LY3841136-Placebo
Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
Interventions:
Drug: LY3841136-Placebo
Drug: Tirzepatide
Experimental: Part B: LY3841136 + Tirzepatide-Placebo
LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
Interventions:
Drug: LY3841136
Drug: Tirzepatide-Placebo
Experimental: Part B: LY3841136 + Tirzepatide
LY3841136 administered SC along with Tirzepatide administered SC
Interventions:
Drug: LY3841136
Drug: Tirzepatide
Placebo Comparator: Part B: LY3841136-Placebo + Tirzepatide-Placebo
Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC
Interventions:
Drug: LY3841136-Placebo
Drug: Tirzepatide-Placebo

Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
[Time Frame: Baseline through Week 22]

Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
[Time Frame: Baseline through Week 34]

+81-92-283-7701

Feb. 08, 2024

No

none