Phase 1
Completed N=16
Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
Renal Impairment
Source: ClinicalTrials.gov NCT05711381 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Maximum Serum Concentration (Cmax) of HM15912 — 2811.25; 3000.00 ng/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Concentration (Cmax) of HM15912 |
2811.25; 3000.00 | — |
| PRIMARY Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912 |
1117469.3; 890343.8 | — |
| SECONDARY Overall Summary of Treatment-emergent Adverse Events (TEAEs) |
1; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
All Subjects
- Subjects voluntarily agreed to participate in this study and sign an institutional review board (IRB)-approved informed consent form prior to performing any of the S1 procedures.
- Males and females ≥ 18 and ≤ 80 years of age at S1.
- Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m^2.
Subjects with Normal Renal Function
- No clinically relevant abnormalities identified by detailed medical history, full physical examination, including blood pressure (BP) and heart rate (HR) measurements, 12-lead ECG, and clinical laboratory tests.
- Normal renal function (eGFR ≥ 90 mL/min/1.73m^2) at screening based on the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation.
- Demographically comparable to the group of subjects with impaired renal function.
Subjects with Impaired Renal Function
- Met the following eGFR criteria during the screening period based on the CKD-EPI equation:
- Severe renal impairment: eGFR 450 msec in males or QTcF > 470 msec in females.
Additional Exclusion Criteria for Subjects with Impaired Renal Function
- Subject with clinically significant active diseases that may have affected the safety of the subject or that may have affected the PK of HM15912 (including drug allergies, but excluding treatment not required, asymptomatic, seasonal allergies at time of dosing). Subjects with any significant hepatic, cardiac, or pulmonary disease or subjects who were clinically nephrotic. Hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease, etc. were not causes for exclusion as long as the subject was medically stable and any drugs that were administered for these conditions were not expected to interfere with the PK of HM15912.
- Subject who had a mean BP ≥ 180 mm Hg (systolic) or ≥ 120 mm Hg (diastolic). After at least 5 minutes of supine rest, measurements were taken 2 consecutive times at least 2 minutes apart. If the mean of the 2 BP was ≥ 180 mm Hg (systolic) or ≥ 120 mmHg (diastolic), the BP should have been repeated 1 more time and the average of the 3 BP values should have been used to determine the subject's eligibility.
- Subject who had a baseline QTcF > 480 msec.
Data sourced from ClinicalTrials.gov (NCT05711381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.