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Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
NCT05711381 · View on ClinicalTrials.gov ↗
Study Summary
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
Conditions Studied
Interventions
- DRUG HM15912
Study Locations (4)
Florida
- Clinical Pharmacology of Miami — Miami
- Panax Clinical Research — Miami Lakes
California
- Orange County Research Center — Tustin
Tennessee
- AMR Knoxville — Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05711381
The ClinicalTrials.gov registry entry for NCT05711381 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 98 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention — of which HM15912 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05711381 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05711381 about?
NCT05711381 is a clinical study titled "Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function". An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
What is the current status of trial NCT05711381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-12-02. Estimated completion is 2023-08-15.
What conditions does trial NCT05711381 study?
This clinical trial studies the following conditions: Renal Impairment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05711381?
The interventions under investigation include: HM15912 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05711381?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 98 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05711381 being conducted?
This trial has 4 study locations across California, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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