Trial Outcomes & Findings for Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities (NCT NCT04167553)
NCT ID: NCT04167553
Last Updated: 2025-01-27
Results Overview
To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
after multiple subcutaneous (SC) doses for 12 weeks
Results posted on
2025-01-27
Participant Flow
The study was to consist of up to 7 cohorts with a total of 102 subjects. Part 1 of the study was to consist of 3 sequential dosing cohorts, enrolling 12 subjects per cohort, for a total of 36 subjects. Part 2 of the study was to consist of up to 4 cohorts, with 30 subjects in Cohort 4 and 12 subjects per cohort for Cohorts 5-7, for a total of 66 subjects. However, during cohort 5 (0.06mg/kg) in Part 2, enrolled subjects safety data were evaluated, and decided to stop the cohort.
During cohort 0.06mg/kg in Part 2(cohort 5), enrolled subjects safety data were evaluated, and decided to stop the cohort. The following cohorts, cohort 6-7, were not conducted since those were optional.
Participant milestones
| Measure |
HM15136 0.02 mg/kg Part 1
In Part 1, 0.02mg/kg cohort, there are 9 subjects.
|
HM15136 0.04 mg/kg Part 1
In Part 1, 0.04mg/kg cohort, there are 9 subjects.
|
HM15136 0.06 mg/kg Part 1
In Part 1, 0.06mg/kg cohort, there are 9 subjects.
|
Placebo Part 1
Placebo: In Part 1, placebo cohort, there are 9 subjects.
|
HM15136 0.02 mg/kg Part 2
In Part 2, 0.02mg/kg cohort 4, there are 9 subjects.
|
HM15136 0.06 mg/kg Part 2
In Part 2, 0.06mg/kg cohort 5, there are 3 subjects enrollment of new subjects into Cohort 5 terminated with a lower number of subjects than planned (30).
|
Placebo Part 2
In Part 2, placebo cohort, there are 4 subjects
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
9
|
3
|
4
|
|
Overall Study
COMPLETED
|
8
|
9
|
6
|
7
|
6
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
2
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
HM15136 0.02 mg/kg Part 1
In Part 1, 0.02mg/kg cohort, there are 9 subjects.
|
HM15136 0.04 mg/kg Part 1
In Part 1, 0.04mg/kg cohort, there are 9 subjects.
|
HM15136 0.06 mg/kg Part 1
In Part 1, 0.06mg/kg cohort, there are 9 subjects.
|
Placebo Part 1
Placebo: In Part 1, placebo cohort, there are 9 subjects.
|
HM15136 0.02 mg/kg Part 2
In Part 2, 0.02mg/kg cohort 4, there are 9 subjects.
|
HM15136 0.06 mg/kg Part 2
In Part 2, 0.06mg/kg cohort 5, there are 3 subjects enrollment of new subjects into Cohort 5 terminated with a lower number of subjects than planned (30).
|
Placebo Part 2
In Part 2, placebo cohort, there are 4 subjects
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities
Baseline characteristics by cohort
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=9 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=3 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
52 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
3 participants
n=8 Participants
|
4 participants
n=8 Participants
|
52 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: after multiple subcutaneous (SC) doses for 12 weeksPopulation: To evaluate Skin and subcutaneous tissue disorders occurance from baseline to end of treatment
To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=6 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=2 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
To Evaluate the Incidence of AEs
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: after multiple subcutaneous (SC) doses for 12 weeksPopulation: incidence of clinical lab abnormalities comparing from baseline to end of treatment
To evaluate the incidence of clinical lab abnormalities of serum amylase
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=8 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=6 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=7 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=6 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=1 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
To Evaluate Serum Amylase Levels at 12 Weeks
|
0.1 U/L
Standard Deviation 12.17
|
-1.1 U/L
Standard Deviation 8.13
|
7.8 U/L
Standard Deviation 8.93
|
-3.6 U/L
Standard Deviation 8.18
|
-12.5 U/L
Standard Deviation 50.69
|
-2 U/L
Standard Deviation NA
n=1 so there was no SD
|
-11 U/L
Standard Deviation 15.21
|
PRIMARY outcome
Timeframe: after multiple subcutaneous (SC) doses for 12 weeksPopulation: Evaluation of body temperature from baseline to end or treatment
tympanic temperature change
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=9 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=1 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tympanic Temperature
|
-0.28 Celsius
Standard Deviation 0.471
|
-0.08 Celsius
Standard Deviation 0.291
|
-0.23 Celsius
Standard Deviation 0.372
|
-0.10 Celsius
Standard Deviation 0.408
|
-0.1 Celsius
Standard Deviation 0.533
|
-0.1 Celsius
Standard Deviation NA
n=1 so there was no SD
|
-0.03 Celsius
Standard Deviation 0.411
|
PRIMARY outcome
Timeframe: after multiple subcutaneous (SC) doses for 12 weeksPopulation: To evaluate 12-lead ECG parameters changes from baseline to end of treatment
QT interval corrected for HR using Fridericia's correction \[QTcF\]
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=6 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=1 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in 12-lead ECG Parameters
|
-26.6 msec
Standard Deviation 22.40
|
-13.5 msec
Standard Deviation 14.98
|
20.5 msec
Standard Deviation 10.14
|
-13.2 msec
Standard Deviation 14.02
|
-10 msec
Standard Deviation 18.24
|
10.3 msec
Standard Deviation NA
N=1, so there was no SD
|
14.0 msec
Standard Deviation 10.85
|
PRIMARY outcome
Timeframe: after multiple subcutaneous (SC) doses for 12 weeksInjection site reactions occurance
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=9 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=3 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
Injection Site Reactions
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to end of treatment (12 weeks)Population: Change Cholesterol from baseline to end of treatment
Change Cholesterol from baseline to end of treatment (12 weeks)
Outcome measures
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 Participants
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 Participants
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 Participants
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 Participants
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=6 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=1 Participants
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 Participants
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
Serum Lipid Profiles
|
-4.94 mg/dL
Standard Error 3.71
|
1.15 mg/dL
Standard Error 3.68
|
2.56 mg/dL
Standard Error 4.07
|
-3.69 mg/dL
Standard Error 3.94
|
-7.41 mg/dL
Standard Error 19.01
|
30.52 mg/dL
Standard Error NA
n=1 so there is no SE
|
-0.25 mg/dL
Standard Error 8.79
|
Adverse Events
HM15136 0.02 mg/kg Part 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HM15136 0.04 mg/kg Part 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HM15136 0.06 mg/kg Part 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Part 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HM15136 0.02 mg/kg Part 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HM15136 0.06 mg/kg Part 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Part 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HM15136 0.02 mg/kg Part 1
n=9 participants at risk
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.04 mg/kg Part 1
n=9 participants at risk
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.06 mg/kg Part 1
n=9 participants at risk
HM15136 0.06 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
Placebo Part 1
n=9 participants at risk
Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
|
HM15136 0.02 mg/kg Part 2
n=9 participants at risk
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
HM15136 0.06 mg/kg Part 2
n=3 participants at risk
HM15136 0.06 mg/kg Part 2
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
Placebo Part 2
n=4 participants at risk
In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
22.2%
2/9 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
44.4%
4/9 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
22.2%
2/9 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
22.2%
2/9 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
0.00%
0/3 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
75.0%
3/4 • Screening, week 1, week 3, week 5, week 9, week 13, week 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place