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A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Plain-language guide to NCT06297616: phase 1 randomized trial of Tirzepatide and Eloralintide, 128 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06297616
Phase
phase 1
Status
completed
Start
2024-04-15
Completion (planned or actual)
2025-11-21
Participants
128 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Tirzepatide and Eloralintide.

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.

It had six arms (groups): Part A: LY3841136 (experimental), Part A: Placebo (placebo comparator), Part B: Tirzepatide + LY3841136-Placebo (experimental), Part B: LY3841136 + Tirzepatide-Placebo (experimental) and Part B: LY3841136 + Tirzepatide (experimental).

LY3841136 administered subcutaneously (SC).

Placebo administered SC.

Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 128 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-15 with completion listed for 2025-11-21.

It ran at 3 sites in Japan (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 (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 (time frame: Baseline through Week 34).

It also tracked 6 secondary outcomes, for example Part A PK: Maximum Observed Concentration (Cmax) of LY3841136, Part B PK: AUC of LY3841136 in Combination with Tirzepatide, Part B PK: Cmax of LY3841136 in Combination with Tirzepatide and Part B PD: Change From Baseline in Body Weight at Week 24.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Eloralintide in 128 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Eloralintide compound page, all human trials.

Our Notes on the Compounds

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Eloralintide: An investigational selective amylin-receptor agonist studied in once-weekly phase 2 obesity trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.