Current partner codePEPTIDESDE
NCT05611957·Phase 1·INTERVENTIONAL

A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Status

Completed

Phase

Phase 1

Enrollment

29

Locations

4

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 5 weeks, excluding screening.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC.

Timeline

From registration to results.

  1. First posted

    Nov 10, 2022

  2. Study start

    Nov 16, 2022

  3. Primary completion

    Sep 5, 2023

  4. Study completion

    Sep 5, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Oct 2, 2023

Outcomes

What the study measures.

Primary outcomes

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943

Time frame · Predose up to 31 days postdose

PK: AUC0-∞ of LY3437943

PK: Maximum observed concentration (Cmax) of LY3437943

Time frame · Predose up to 31 days postdose

PK: Cmax of LY3437943

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: Normal Participants: * Healthy male and female participants as determined by physical examination * Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min). * Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²) * Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate. Participants with Renal Impairment: * Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator * Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5% * Are males or females with severe renal impairment as determined by a stable eGFR \<30 mL/min, not requiring hemodialysis OR * Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months) Exclusion Criteria: * Have known allergies to LY3437943 or related compounds * Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed * Have any abnormality in the 12-lead electrocardiogram (ECG) * Are women with a positive pregnancy test or women who are lactating

Study locations

4 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Orange County Research Center

Tustin, California, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Nucleus Networks

Saint Paul, Minnesota, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.