JRCT ID: jRCT2071230129
Registered date:15/03/2024
A Study of LY3841136 in Japanese Participants With Obesity or Overweight
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Obesity Overweight |
Date of first enrollment | 05/04/2024 |
Target sample size | 70 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Drug: LY3841136 Administered SC Drug: Placebo Administered SC [Study Arms] Experimental: LY3841136 LY3841136 administered subcutaneously (SC) Intervention: Drug: LY3841136 Placebo Comparator: Placebo Placebo administered SC Intervention: Drug: Placebo |
Outcome(s)
Primary Outcome | Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through 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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 65age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Wakayama Naohiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06297616 |
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 |
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 |
LTG_CallCenter@lists.lilly.com | |
Affiliation | Eli Lilly Japan K.K. |