A Study of Brenipatide (LY3537031) Comparing Two Formulations in Healthy Adults

Trial details

Who runs it

Xavier University of Louisiana.

Trial code

NCT07927309

Record updated

10 November 2026

Original description

The SOLE PURPOSE PILOT will be implemented in participating African Methodist Episcopal (AME) churches in Louisiana using a community-based approach that integrates structured education, standardized foot risk assessment, and facilitated clinical referral.Read full original descriptionShow less

A Phase 1, Open-Label, Randomized, Crossover, Bioequivalence Study to Compare the Pharmacokinetics of Two Different Formulations of Brenipatide (LY3537031) Administered Via Pre-filled Syringe, in Healthy Participants

The SOLE PURPOSE PILOT will be implemented in participating African Methodist Episcopal (AME) churches in Louisiana using a community-based approach that integrates structured education, standardized foot risk assessment, and facilitated clinical referral.

Eligible participants will provide informed consent and complete baseline assessments addressing demographic characteristics, diabetes history, foot health knowledge, self-care practices, perceived risk, and self-efficacy. Participants will undergo a standardized foot risk assessment that may include visual inspection for ulcers, calluses, deformities, and other abnormalities; sensory testing using a monofilament; pedal pulse assessment; ankle-brachial index measurement when indicated; and evaluation of footwear and relevant clinical history. Screening findings will be documented using standardized data collection instruments.

The educational intervention will consist of three interactive sessions delivered over a 4- to 6-week period. Sessions will address: (1) recognition of diabetes-related foot complications and individual risk factors; (2) daily foot self-examination, preventive self-care, and appropriate footwear; and (3) recognition of warning signs requiring prompt medical attention, healthcare navigation, and self-advocacy. Educational activities will incorporate culturally relevant examples, demonstrations, and opportunities for participants to practice foot care skills.

Participants with screening findings indicating the need for additional clinical evaluation will receive facilitated referrals through a coordinated patient navigation process. Referral urgency will be determined by the clinical findings and established referral procedures. Patient navigators will assist with care coordination, appointment scheduling, identification of barriers to care, and follow-up to document referral outcomes.

Participants will be followed for three months after enrollment. Follow-up assessments will document completion of recommended foot evaluations, changes in foot health knowledge and self-care behaviors, self-efficacy, and referral outcomes. Implementation measures will include recruitment and participation, intervention delivery, fidelity to study procedures, participant acceptability, and adoption within participating church settings.

Study data will be collected using standardized instruments and managed according to approved institutional research procedures. Descriptive analyses will characterize participant demographics, baseline foot risk, intervention participation, screening findings, and referral outcomes. Exploratory analyses will examine changes in participant-reported measures and the proportion completing recommended clinical evaluations. Implementation findings will be used to identify operational barriers, facilitators, and considerations for future program refinement and scale-up.

Inclusion: Resides in Louisiana or receives healthcare services in Louisiana; Meets at least one of the following elevated foot-risk criteria:; Previous diabetic foot ulcer or lower extremity amputation. Self-reported symptoms of peripheral neuropathy, including numbness, tingling, or burning sensations in the feet; Current or recent foot callus, deformity, lesion, or other foot abnormality. Insulin use or diabetes duration of 10 years or longer. Known chronic kidney disease, peripheral artery disease, or previous diabetes-related hospitalization; Current or recent tobacco smoking. Able and willing to provide informed consent. Willing to participate in the church-based educational intervention, foot risk screening, and follow-up assessments.

Exclusion: Younger than 18 years of age. No diagnosis of diabetes mellitus. Does not meet any of the specified elevated foot-risk criteria. Unable to provide informed consent. Unwilling or unable to participate in the study intervention or required follow-up assessments.

ClinicalTrials.gov NCT07927309