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A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity
Plain-language guide to NCT06916065: phase 1 non-randomized trial of Tirzepatide and Eloralintide, 188 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06916065
- Phase
- phase 1
- Status
- completed
- Start
- 2025-04-09
- Completion (planned or actual)
- 2026-01-19
- Participants
- 188 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Overweight; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Tirzepatide and Eloralintide.
The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity.
The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.
It had two arms (groups): Eloralintide and Tirzepatide-Cohorts A-D (experimental) and Eloralintide-Cohorts E and F (experimental).
Eloralintide and Tirzepatide administered subcutaneously (SC).
Eloralintide administered SC.
The registry classes the interventions as drug.
Who Took Part
188 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: Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive.
The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations; have a history or presence of a gastrointestinal (gi) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis; have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Tirzepatide study did not mask who received what.
It started in 2025-04-09 with completion listed for 2026-01-19.
It ran at 3 sites in United States (3).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide (time frame: Day 106 Predose to Approximately Week 26). Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide (time frame: Baseline Up to Approximately Week 11). Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide (time frame: Baseline Up to Approximately Week 11).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Tirzepatide and Eloralintide in 188 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.