NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071230129

Registered date:15/03/2024

A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedObesity Overweight
Date of first enrollment15/04/2024
Target sample size128
Countries of recruitment
Study typeInterventional
Intervention(s)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

Outcome(s)

Primary OutcomePart 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]
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 65age old
GenderBoth
Include criteriaMale 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
Exclude criteriaHave 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

Related Information

Contact

Public contact
Name Trial Guide Call Center
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name Naohiko Wakayama
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.