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Phase 1 eloralintide with tirzepatide (NCT06345066)

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Trial record

Trial name
Phase I, multiple-dose combination with tirzepatide
Registry identifier
NCT06345066
Phase
Phase I
Sponsor
Eli Lilly and Company
Population
Adults with overweight or obesity
Intervention
Eloralintide (LY3841136) in combination with tirzepatide
Comparator
Placebo and tirzepatide
Enrollment
96
Study status
Completed (confirmed 2026-10-01 via ClinicalTrials.gov; completed 2025-09-29)
Start date
2024-04-03
Completion date
2025-09-29
Results availability
No results posted on ClinicalTrials.gov as of 2026-10-01

Primary endpoints

  • Primary: number of participants with treatment-related adverse events and serious adverse events, baseline up to 42 weeks. Secondary: percent change in body weight at week 42; eloralintide pharmacokinetics (AUC and Cmax) (ClinicalTrials.gov, confirmed 2026-10-01)

Primary registry record

A trial registration shows that a study exists. It does not show that the compound works, is safe, or has been approved, and recruitment says nothing about the eventual result.

This multiple-dose Phase 1 study assessed the safety and tolerability of eloralintide given with tirzepatide in people with overweight or obesity. It lasted up to about 42 weeks and ran at 3 United States sites.

Read with care: A registry record describes a study’s plan and status. It is not a result, and it does not show that the drug works or is safe.

Study context

What the study tests

This Phase 1 study looks at the safety and tolerability of eloralintide (listed as LY3841136) given together with tirzepatide in adults with overweight or obesity, with placebo as a comparator. The primary endpoint is the number of participants with treatment-related adverse events and serious adverse events. Percent change in body weight at week 42 and drug levels are secondary measures. The record lists 96 participants and about 42 weeks per participant.

Who can take part

Adults aged 18 to 65 who are otherwise healthy, with a stable body weight and a BMI from 27 to 45. People with type 1 or type 2 diabetes, an abnormal ECG, abnormal blood pressure or pulse, or a history of psychiatric disorders are excluded. Sites are in Florida, Texas and Wisconsin.

What the registry does not say

The study is marked completed, with primary completion on 29 September 2025, and no results are posted. Because the primary endpoint is safety, the week 42 weight measure is a registered secondary plan, not a conclusion.

Source: ClinicalTrials.gov record NCT06345066, read on 2026-10-15. Registered plans can change.

References

  1. US National Library of Medicine. ClinicalTrials.gov registry records for the eloralintide clinical program. ClinicalTrials.gov. P1