TerminatedPhase 1Results posted

A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants

A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of the Oxyntomodulin Analog, LY2944876, in Healthy Japanese Subjects and Healthy Non-Japanese Subjects

Lead sponsor

OPKO Health, Inc.

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 18.5-30•Healthy volunteers

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02188303

Org study ID15247

Secondary IDI7I-EW-XNABEli Lilly and Company

Timeline

Milestones

Study first posted2014-07-11estimated

Results first posted2021-04-14actual

Last update posted2021-05-27actual

Study start2014-07 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males or female participants

•Are first generation Japanese participants (Part A) or non-Japanese participants (Part B)

•Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m^2), inclusive, for Part A and a BMI of 25 to 40 kg/m^2, inclusive, for Part B at screening

•Have normal blood pressure and heart rate (after approximately 5 minutes supine and approximately 2 minutes standing) as determined by the investigator at screening

Exclusion criteria

•Have known allergies to LY2944876, related compounds or any components of the formulation, or history of significant atopy

•Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or baseline that, in the opinion of the investigator, increases the risks associated with participating in the study

•Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

•Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 2 times the upper limit of normal (ULN) at screening and/or baseline

•Have known or ongoing psychiatric disorders considered clinically significant in the opinion of the investigator

•Have undergone any form of bariatric surgery

•Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter (mmol/L) [≥126 milligrams per deciliter (mg/dL)] at screening

•Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening

•Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater than (>) 2.5 times the ULN at screening and/or baseline

•Have used or intend to use medications that promote weight loss, within 3 months prior to screening, for the duration of the study

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration

Time frame:Pre-dose (PRD) through Study Completion (Up to Day 40)

Serious AEs (any)

event count, event

Posted result

Group	Number · Participants	95% CI
Cohorts 1-3 - Placebo	0	-
Cohort 1 - 10 mg LY2944876	0	-
Cohort 2 - 30 mg LY2944876	0	-
Cohort 3 - 50 mg LY2944876	0	-
Cohort 4 - Placebo	0	-
Cohort 4 - 40 mg LY2944876	0	-
Cohort 5 - Placebo	0	-
Cohort 5 - 15-60 mg Titrated LY2944876	0	-

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876

Time frame:Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanograms∙hours/milliliters (ng∙h/mL)	95% CI
Cohort 1 - 10 mg LY2944876	105000	-
Cohort 2 - 30 mg LY2944876	307000	-
Cohort 3 - 50 mg LY2944876	495000	-
Cohort 4 - 40 mg LY2944876	1789000	-
Cohort 5 - 15-60 mg Titrated LY2944876	803000	-

Secondary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms/milliliter (ng/mL)	95% CI
Cohort 1 - 10 mg LY2944876	790	-
Cohort 2 - 30 mg LY2944876	2360	-
Cohort 3 - LY2944876 50 mg	3640	-
Cohort 4 - 40 mg LY2944876	11700	-
Cohort 5 - 15-60 mg Titrated LY2944876	5470	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.