A Study of Brenipatide (LY3537031) Comparing Two Formulations in Healthy Adults
NCT07927309, Not applicable, Not yet recruiting, Xavier University of Louisiana.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Brenipatide (LY3537031) Comparing Two Formulations in Healthy Adults | ClinicalTrials.gov |
| NCT number | NCT07927309 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Xavier University of Louisiana. | ClinicalTrials.gov |
| Conditions | Diabetes (DM), Foot Ulcer Due to Type 2 Diabetes Mellitus, Neuropathic Diabetic Ulcer - Foot | ClinicalTrials.gov |
| Interventions | SOLE PURPOSE Church-Based Foot Health Intervention | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants Completing a Guideline-Concordant Foot Evaluation | Within 3 months of baseline screening | The proportion of enrolled participants who complete a guideline-concordant foot evaluation within three months of baseline screening. A qualifying evaluation includes a podiatry visit, comprehensive primary care diabetic foot examination with documented risk stratification, wound clinic visit, or vascular evaluation when clinically indicated. Completion will be determined through participant self-report, referral tracking logs, and medical record confirmation when available. The outcome will be calculated as the number of participants completing a qualifying evaluation divided by the total number of enrolled participants, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Change in Foot Health Literacy and Knowledge Scores | Baseline, immediately post-intervention, and 3 months after baseline. | Change in foot health knowledge will be measured using a study-specific questionnaire assessing recognition of diabetic foot warning signs, appropriate care-seeking, daily foot self-examination, preventive footwear practices, and common misconceptions. Scores will be compared across assessment time points, with higher scores indicating greater knowledge. | ClinicalTrials.gov |
| Secondary | Change in Foot Self-Care Behavior Score | Baseline and 3 months after baseline | Change in foot self-care behaviors will be assessed using the foot-care subscale of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire or an equivalent measure. Behaviors assessed include daily foot inspection, appropriate footwear use, avoidance of walking barefoot, and timely reporting of foot problems. Scores will be compared between baseline and three-month follow-up, with higher scores indicating greater adherence to recommended foot self-care practices. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Completing Foot Risk Screening | Baseline (at enrollment) | The proportion of enrolled participants who complete a standardized baseline foot risk assessment at a participating church event or linked clinical site. Screening completion will be documented using study assessment records. The measure will be calculated as the number of participants completing the assessment divided by the total number enrolled, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Referral Completion Rate Among Participants Requiring Follow-Up | Within 3 months of baseline screening | Among participants classified as Tier 2 or Tier 3 based on standardized foot risk screening and referred for additional clinical evaluation, the proportion who complete the recommended evaluation within three months of baseline screening. Referral completion will be assessed using patient navigation records, participant self-report, and clinical documentation when available. The denominator will include all participants receiving a qualifying referral. | ClinicalTrials.gov |
| Secondary | Change in Foot Care Self-Efficacy Score | Baseline, immediately post-intervention, and 3 months after baseline | Change in participants' confidence in performing daily foot self-examinations, recognizing warning signs, and seeking appropriate professional care will be assessed using study-specific Likert-scale items or a validated self-efficacy instrument. Scores will be compared at baseline, immediately following the educational intervention, and at three-month follow-up. Higher scores will indicate greater confidence in managing foot health. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)