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

NCT05711381 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HM-GLP2-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief 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

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• Maximum Serum Concentration (Cmax) of HM15912

  Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.

  Day 1 to 29 (Total duration: 29 days)

• Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912

  PK samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.

  Day 1 to 29 (Total duration: 29 days)

Secondary Outcomes (1)

• Overall Summary of Treatment-emergent Adverse Events (TEAEs)

  Day 1 up to Day 29

Study Arms (4)

Severe renal impairment

EXPERIMENTAL

Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis

Drug: HM15912

Normal renal function

EXPERIMENTAL

Subjects with eGFR ≥ 90 mL/min/1.73m\^2

Drug: HM15912

Moderate renal impairment

EXPERIMENTAL

Subjects with 30 mL/min/1.73m\^2 ≤ eGFR \< 60 mL/min/1.73m\^2

Drug: HM15912

Mild renal impairment

EXPERIMENTAL

Subjects with 60 mL/min/1.73m\^2 ≤ eGFR \< 90 mL/min/1.73m\^2

Drug: HM15912

Interventions

HM15912 DRUG

Singe subcutaneous administration of HM15912 0.5 mg/kg

Also known as: Sonefpeglutide

Mild renal impairment; Moderate renal impairment; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 30 mL/min/1.73m\^2, but not requiring hemodialysis.
• Moderate renal impairment: 30 mL/min/1.73m\^2 ≤ eGFR \< 60 mL/min/1.73m\^2
• Mild renal impairment: 60 mL/min/1.73m\^2 ≤ eGFR \< 90 mL/min/1.73m\^2

You may not qualify if:

• All Subjects:
• Renal transplant recipients or subjects requiring hemodialysis and peritoneal dialysis.
• Subject with a history or presence of any psychiatric disorder that, in the opinion of the Investigator, might have confounded the results of the study or posed additional risk in administering the IP to the subject.
• Had participated in an interventional clinical trial (investigational or marketed product) 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 IP components.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (GI), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding treatment not required, asymptomatic, seasonal allergies at the time of dosing).
• Subject who had a mean BP ≥ 140 mmHg (systolic) or ≥ 90 mmHg (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 ≥ 140mmHg (systolic) or ≥ 90 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 corrected QT using the Fridericia correction formula (QTcF) \> 450 msec in males or QTcF \> 470 msec in females.
• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (4)

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Moon Hee Lee, MD
• Organization: Hanmi Pharmaceutical Co., Ltd.

mhlee7@hanmi.co.kr

+82 2 410 9062

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: February 3, 2023
• Study Start: December 2, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)