NCT07738614

Brief Summary

The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
4mo left

Started Jul 2026

Shorter than P25 for phase_1 obesity

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 1, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

ObesityOverweight

Keywords

Healthy

Outcome Measures

Primary Outcomes (3)

  • Acetaminophen Area Under the Concentration Versus Time Curve (AUC)

    Baseline to Day 65

  • Acetaminophen Maximum Observed Concentration (Cₘₐₓ)

    Baseline to Day 65

  • Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ)

    Baseline to Day 65

Secondary Outcomes (2)

  • Eloralintide AUC

    Baseline to Day 106

  • Eloralintide Cₘₐₓ

    Baseline to Day 106

Study Arms (5)

Eloralintide Cohort 1

EXPERIMENTAL

Eloralintide administered subcutaneously (SC)

Drug: EloralintideDrug: Acetaminophen

Eloralintide Cohort 2

EXPERIMENTAL

Eloralintide administered SC

Drug: EloralintideDrug: Acetaminophen

Eloralintide Cohort 3

EXPERIMENTAL

Eloralintide administered SC

Drug: EloralintideDrug: Acetaminophen

Eloralintide Cohort 4

EXPERIMENTAL

Eloralintide administered SC

Drug: EloralintideDrug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: PlaceboDrug: Acetaminophen

Interventions

EloralintideDRUG

Administered SC

Also known as: LY3841136
Eloralintide Cohort 1Eloralintide Cohort 2Eloralintide Cohort 3Eloralintide Cohort 4
PlaceboDRUG

Administered SC

Placebo
AcetaminophenDRUG

Administered Oral Solution

Eloralintide Cohort 1Eloralintide Cohort 2Eloralintide Cohort 3Eloralintide Cohort 4Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have overweight or obesity, but are otherwise overtly healthy.
  • Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive.
  • Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.

You may not qualify if:

  • Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening
  • A fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)/deciliter (dL) or 7.0 millimoles (mmol)/liter (L), or
  • Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol/mole (mol).
  • Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.
  • Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, or GIP/GLP-1/glucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.
  • Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)SG(1)