GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05757531

CompletedPhase 1

A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants

Disposition of [14C]-LY3437943 Following Subcutaneous Administration in Healthy Male Participants

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-32•Male•Healthy volunteers

Primary endpoints

•Urinary Excretion of LY3437943 Radioactivity Over Time Expressed as•Fecal Excretion of LY3437943 Radioactivity Over Time Expressed as a Percentage

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05757531

Org study ID18217

Secondary IDJ1I-MC-GZBGEli Lilly and Company

Timeline

Milestones

Study first posted2023-03-07actual

Study start2023-03-17actual

Primary completion2023-06-23actual

Study completion2023-06-23actual

Last update posted2023-07-05actual

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male participants who are overtly healthy as determined by medical evaluation

•Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)

•Have clinical laboratory test results within normal reference range for the population or investigative site, or results outside the normal reference range that are judged to be not clinically significant by the investigator. Participants with dyslipidemia may be included in the study, at the discretion of the investigator, as long as they fulfill other eligibility criteria

•Have venous access sufficient to allow for blood sampling as per the protocol

•Are willing to receive study treatment by SC injections

•Have a history of a minimum of 1 bowel movement per day

•Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria

•Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in

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

•Have evidence of significant active neuropsychiatric disease, as determined by the investigator

•Show evidence of HIV infection and/or positive HIV antibodies, hepatitis C and/or positive hepatitis C antibody, hepatitis B and/or positive hepatitis B surface antigen

•Have a history of constipation or have had acute constipation within 3 weeks prior to check-in

•Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of less than 70 mL/minute, calculated using the Chronic Kidney Disease-Epidemiology equation

•Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) and/or elevation in serum amylase or lipase (greater than 1.5-fold the ULN) at screening

•Have used or plan to use over-the-counter or prescription medication, and/or dietary or herbal supplements (with the exception of vitamin supplements, acetaminophen and/or thyroid replacement therapy) within 14 days or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study, including any medications that reduce GI motility, including, but not limited to, anticholinergics, antispasmodics, 5 hydroxytryptamine-3 receptor antagonists, dopamine antagonists, and opiates

•Have had exposure to significant radiation within 12 months prior to dosing (eg, serial x-ray or CT scans, barium meal, being employed in a job requiring radiation exposure monitoring)

•Have participated in any clinical trial involving a radiolabeled substance within the past 12 months

Endpoints (6)

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

6 endpoints

Primary/protocol endpoint

Urinary Excretion of LY3437943 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered