Trial Outcomes & Findings for Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function (NCT NCT05711381)
NCT ID: NCT05711381
Last Updated: 2025-04-04
Results Overview
Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 1 to 29 (Total duration: 29 days)
Results posted on
2025-04-04
Participant Flow
A single-dose, open-label, phase 1 study, which was to characterize the effect of RI on the PK of HM15912, was planned to be conducted in 2 parts. A total of 16 subjects, 8 subjects with severe RI (Cohort 2) and 8 subjects with normal renal function (Cohort 1), were enrolled for Part 1. Part 2 of the study, which was optional to evaluate the effect of moderate and mild renal impairment on the PK of HM15912 following a single SC dose, was not conducted based on the results from Part 1.
Participant milestones
| Measure |
Severe Renal Impairment
Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
Subjects with eGFR ≥ 90 mL/min/1.73m\^2, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Moderate Renal Impairment (Part 2 Only)
Subjects with 30 mL/min/1.73m\^2 ≤ eGFR \< 60 mL/min/1.73m\^2
|
Mild Renal Impairment (Part 2 Only)
Subjects with 60 mL/min/1.73m\^2 ≤ eGFR \< 90 mL/min/1.73m\^2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
8
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety population
Baseline characteristics by cohort
| Measure |
Severe Renal Impairment
n=8 Participants
Subjects with eGFR \< 30 mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
n=8 Participants
Subjects with eGFR≥ 90 mL/min/1.73m\^2 received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Safety population
|
0 Participants
n=7 Participants • Safety population
|
0 Participants
n=5 Participants • Safety population
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants • Safety population
|
8 Participants
n=7 Participants • Safety population
|
12 Participants
n=5 Participants • Safety population
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants • Safety population
|
0 Participants
n=7 Participants • Safety population
|
4 Participants
n=5 Participants • Safety population
|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 3.25 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 6.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • Safety population
|
2 Participants
n=7 Participants • Safety population
|
4 Participants
n=5 Participants • Safety population
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • Safety population
|
6 Participants
n=7 Participants • Safety population
|
12 Participants
n=5 Participants • Safety population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants • Safety population
|
6 Participants
n=7 Participants • Safety population
|
10 Participants
n=5 Participants • Safety population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants • Safety population
|
2 Participants
n=7 Participants • Safety population
|
6 Participants
n=5 Participants • Safety population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Safety population
|
0 Participants
n=7 Participants • Safety population
|
0 Participants
n=5 Participants • Safety population
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Estimated glomerular filtration rate
|
17.145 mL/min/1.73m^2
STANDARD_DEVIATION 7.5206 • n=5 Participants
|
97.864 mL/min/1.73m^2
STANDARD_DEVIATION 4.2156 • n=7 Participants
|
57.504 mL/min/1.73m^2
STANDARD_DEVIATION 42.0970 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 29 (Total duration: 29 days)Population: PK population: All subjects who had at least one evaluable HM15912 serum concentration after receiving any amount of HM15912 without IPDs or events.
Pharmacokinetic (PK) samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Outcome measures
| Measure |
Severe Renal Impairment
n=8 Participants
Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
n=8 Participants
Subjects with eGFR ≥ 90 mL/min/1.73m\^2, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of HM15912
|
2811.25 ng/mL
Standard Deviation 1498.985
|
3000.00 ng/mL
Standard Deviation 1174.114
|
PRIMARY outcome
Timeframe: Day 1 to 29 (Total duration: 29 days)Population: PK Population: All subjects who had at least one evaluable HM15912 serum concentration after receiving any amount of HM15912 without IPDs or events.
PK samples were collected for measurement of serum concentrations of HM15912 and analyzed using a fully validated method.
Outcome measures
| Measure |
Severe Renal Impairment
n=8 Participants
Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
n=8 Participants
Subjects with eGFR ≥ 90 mL/min/1.73m\^2, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912
|
1117469.3 h*ng/mL
Standard Deviation 347572.67
|
890343.8 h*ng/mL
Standard Deviation 235565.36
|
SECONDARY outcome
Timeframe: Day 1 up to Day 29Population: Safety Population: All subjects who received any amount of HM15912.
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.
Outcome measures
| Measure |
Severe Renal Impairment
n=8 Participants
Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
n=8 Participants
Subjects with eGFR ≥ 90 mL/min/1.73m\^2, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
|---|---|---|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
Any Treatment-Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
Any Treatment-Related Adverse Events (TRAEs)
|
0 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
Any Treatment-Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
Any TEAEs leading to Drug Interruption/Withdrawn
|
0 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs)
any TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
Adverse Events
Severe Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Renal Function
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Severe Renal Impairment
n=8 participants at risk
Subjects with eGFR \< 30mL/min/1.73m\^2, but not requiring hemodialysis, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
Normal Renal Function
n=8 participants at risk
Subjects with eGFR ≥ 90 mL/min/1.73m\^2, received 0.5 mg/kg SC dose of HM15912 on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
12.5%
1/8 • Number of events 1 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
12.5%
1/8 • Number of events 1 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
0.00%
0/8 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
0.00%
0/8 • From the signing of ICF util follow-up visit (about 2 months)
Adverse Event (AE) analyses were to focus on Treatment-Emergent AEs (TEAEs), which were 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place