Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function

Inclusion Criteria:

All Subjects

• Subjects voluntarily agreed to participate in this study and sign an institutionalreview board (IRB)-approved informed consent form prior to performing any of the S1procedures.

• 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, fullphysical 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 chronickidney 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-EPIequation:

1. Severe renal impairment: eGFR < 30 mL/min/1.73m^2, but not requiringhemodialysis.

2. Moderate renal impairment: 30 mL/min/1.73m^2 ≤ eGFR < 60 mL/min/1.73m^2

3. Mild renal impairment: 60 mL/min/1.73m^2 ≤ eGFR < 90 mL/min/1.73m^2

Exclusion Criteria:

All Subjects:

• Renal transplant recipients or subjects requiring hemodialysis and peritonealdialysis.

• Subject with a history or presence of any psychiatric disorder that, in the opinionof the Investigator, might have confounded the results of the study or posedadditional risk in administering the IP to the subject.

• Had participated in an interventional clinical trial (investigational or marketedproduct) within 1 month of screening or 5 half-lives of the drug under investigation (whichever came first), or planned to participate in another clinical trial.

• Subject with a history of any SAEs, hypersensitivity reactions, or intolerance to IPcomponents.

Additional Exclusion Criteria for Subjects with Normal Renal Function

• Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal (GI), cardiovascular, hepatic, psychiatric,neurological, or allergic disease (including drug allergies, but excluding treatmentnot required, asymptomatic, seasonal allergies at the time of dosing).

• Subject who had a mean BP ≥ 140 mmHg (systolic) or ≥ 90 mmHg (diastolic). After atleast 5 minutes of supine rest, measurements were taken 2 consecutive times at least 2 minutes apart. If the mean of the 2 BP was ≥ 140mmHg (systolic) or ≥ 90 mmHg (diastolic), the BP should have been repeated 1 more time and the average of the 3BP values should have been used to determine the subject's eligibility.

• Subject who had a baseline corrected QT using the Fridericia correction formula (QTcF) > 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 thesafety of the subject or that may have affected the PK of HM15912 (including drugallergies, but excluding treatment not required, asymptomatic, seasonal allergies attime of dosing). Subjects with any significant hepatic, cardiac, or pulmonarydisease or subjects who were clinically nephrotic. Hypertension, diabetes mellitus,hyperparathyroidism, ischemic heart disease, etc. were not causes for exclusion aslong as the subject was medically stable and any drugs that were administered forthese 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). Afterat least 5 minutes of supine rest, measurements were taken 2 consecutive times atleast 2 minutes apart. If the mean of the 2 BP was ≥ 180 mm Hg (systolic) or ≥ 120mmHg (diastolic), the BP should have been repeated 1 more time and the average ofthe 3 BP values should have been used to determine the subject's eligibility.

• Subject who had a baseline QTcF > 480 msec.