Renal ImpairmentPhase 1NCT05711381

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

A Phase 1 study testing HM15912 in people with Renal Impairment, run by Hanmi Pharmaceutical Company Limited at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: HM15912
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 4 sitesUnited States
Study dates: 2 Dec 2022to 15 Aug 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 13Show fewer

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

Who cannot join

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.
Additional Exclusion Criteria for Subjects with Normal Renal Function

Show all 13Show fewer

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.
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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

AMR Knoxville
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami
Miami, Florida, 33014
Panax Clinical Research
Miami Lakes, Florida, 33014
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912(Sonefpeglutide) in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal 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

Read the detailed description

A single-dose, open-label, Phase 1 study (HM-GLP2-102) was conducted to evaluate the impact of renal impairment (RI) on the pharmacokinetics (PK) of HM15912. This study aimed to assess the safety and PK profile of HM15912 at a minimum effective dose of 0.5 mg/kg, which was determined based on findings from a previous clinical study (HM-GLP2-101).

The study was initially designed to be conducted in two parts.

Part 1: An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with severe RI and subjects with normal renal function as a control group.

Part 2 (if applicable): An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with moderate and mild RI.

Conditions: Renal Impairment
Being tested: HM15912
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HM15912Drug
Also called Sonefpeglutide
Singe subcutaneous administration of HM15912 0.5 mg/kg

Study groups in NCT05711381
Study group	Role	What they receive
Severe renal impairment	Experimental	Subjects with eGFR < 30mL/min/1.73m^2, but not requiring hemodialysis Receives: Drug: HM15912
Normal renal function	Experimental	Subjects with eGFR ≥ 90 mL/min/1.73m^2 Receives: Drug: HM15912
Moderate renal impairment	Experimental	Subjects with 30 mL/min/1.73m^2 ≤ eGFR < 60 mL/min/1.73m^2 Receives: Drug: HM15912
Mild renal impairment	Experimental	Subjects with 60 mL/min/1.73m^2 ≤ eGFR < 90 mL/min/1.73m^2 Receives: Drug: HM15912

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 1 to 29 (Total duration: 29 days)

Secondary outcomes (1)

Overall Summary of Treatment-emergent Adverse Events (TEAEs)
The number and percentages of subjects with TEAEs were to be summarized by cohort. A TEAE was defined as any AE that began, or worsened in severity, on or after the date of the first IP administration until the last follow-up visit.
Measured: Day 1 up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202215 Aug 2023

First posted3 Feb 2023
Study start2 Dec 2022
Primary completion15 Aug 2023
Study completion15 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05711381
Sponsor's protocol ID: HM-GLP2-102
Status last verified: Mar 2025
First submitted: 8 Nov 2022
Last updated: 4 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912(Sonefpeglutide) in Subjects With Renal Impairment and Matched Control Subjects With Normal Renal Function
ClinicalTrials.gov ID: NCT05711381
Acronym / sponsor ID: HM-GLP2-102
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 2 Dec 2022 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 3 Feb 2023 (actual)
Results: Posted 4 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The study was initially designed to be conducted in two parts.

Part 2 (if applicable): An open-label, single-dose, parallel-group study to investigate the effect of RI on the PK, safety, and tolerability of HM15912 in subjects with moderate and mild RI.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Severe renal impairment	Experimental	Drug: HM15912Subjects with eGFR < 30mL/min/1.73m^2, but not requiring hemodialysis
Normal renal function	Experimental	Drug: HM15912Subjects with eGFR ≥ 90 mL/min/1.73m^2
Moderate renal impairment	Experimental	Drug: HM15912Subjects with 30 mL/min/1.73m^2 ≤ eGFR < 60 mL/min/1.73m^2
Mild renal impairment	Experimental	Drug: HM15912Subjects with 60 mL/min/1.73m^2 ≤ eGFR < 90 mL/min/1.73m^2

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (13 listed)

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.
Additional Exclusion Criteria for Subjects with Normal Renal Function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HM15912Also: SonefpeglutideSinge subcutaneous administration of HM15912 0.5 mg/kg	Drug	Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment

Primary outcome

Maximum Serum Concentration (Cmax) of HM15912
Time frame: Day 1 to 29 (Total duration: 29 days)
Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912
Time frame: Day 1 to 29 (Total duration: 29 days)
PK samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.

1 secondary outcome

Overall Summary of Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 29

Results and safety

Results posted to the registry on 4 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Severe Renal Impairment	8	8
Normal Renal Function	8	8
Moderate Renal Impairment (Part 2 Only)	0	0
Mild Renal Impairment (Part 2 Only)	0	0

Primary outcome: Maximum Serum Concentration (Cmax) of HM15912

Time frame: Day 1 to 29 (Total duration: 29 days). Mean (Standard Deviation). Unit: ng/mL

Measure	Severe Renal Impairment n = 8	Normal Renal Function n = 8
Value	2811.25 (1498.985)	3000.00 (1174.114)

Severe Renal Impairment vs Normal Renal Function: Geometric mean ratio: 0.91 (90% CI 0.59 to 1.41)

Population analysed: PK population: All subjects who had at least one evaluable HM15912 serum concentration after receiving any amount of HM15912 without IPDs or events.

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

Time frame: Day 1 to 29 (Total duration: 29 days). Mean (Standard Deviation). Unit: h*ng/mL

Measure	Severe Renal Impairment n = 8	Normal Renal Function n = 8
Value	1117469.3 (347572.67)	890343.8 (235565.36)

Severe Renal Impairment vs Normal Renal Function: Geometric mean ratio: 1.25 (90% CI 0.93 to 1.68)

Population analysed: PK Population: All subjects who had at least one evaluable HM15912 serum concentration after receiving any amount of HM15912 without IPDs or events.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the signing of ICF util follow-up visit (about 2 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Severe Renal Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Normal Renal Function	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HM15912 in people with Renal Impairment, run by Hanmi Pharmaceutical Company Limited at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Serum Concentration (Cmax) of HM15912 (time frame: Day 1 to 29 (Total duration: 29 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05711381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.