Clinical trial NCT06297616: A Study of LY3841136 in Japanese Participants With Obesity or Overweight
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Obesity
Overweight
Keywords: Obesity Disease
Metabolic Disorders
Body Weight Loss
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.


Eligibility criteria: Inclusion 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

Exclusion 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
* 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

Primary outcomes:
measure: 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
timeFrame: Baseline through Week 22
measure: 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
timeFrame: Baseline through Week 34
Secondary outcomes:
measure: Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
timeFrame: Predose through Week 22
measure: Part A PK: Maximum Observed Concentration (Cmax) of LY3841136
timeFrame: Predose through Week 22
measure: Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12
timeFrame: Baseline through Week 12
measure: Part B PK: AUC of LY3841136 in Combination with Tirzepatide
timeFrame: Predose through Week 34
measure: Part B PK: Cmax of LY3841136 in Combination with Tirzepatide
timeFrame: Predose through Week 34
measure: Part B PD: Change From Baseline in Body Weight at Week 24
timeFrame: Baseline through Week 24
Other outcomes:
Locations:
city: Hachioji
country: Japan
facility: P-One Clinic
state: Tokyo
city: Sumida-ku
country: Japan
facility: Sumida Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Hakata Clinic
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: