Trial Outcomes & Findings for A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide) (NCT NCT03374241)
NCT ID: NCT03374241
Last Updated: 2025-02-06
Results Overview
An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
1 month
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Cohort 1
HM15211 0.01 mg/kg
|
Cohort 2
HM15211 0.02 mg/kg
|
Cohort 3
HM15211 0.04 mg/kg
|
Cohort 4
HM15211 0.08 mg/kg
|
Cohort 5
HM15211 0.12 mg/kg
|
Placebo
Placebo matched to the volume of the dose of HM15211
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
5
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)
Baseline characteristics by cohort
| Measure |
Cohort 1 Active
n=6 Participants
HM15211 0.01 mg/kg
|
Cohort 2 Active
n=6 Participants
HM15211 0.02 mg/kg
|
Cohort 3 Active
n=6 Participants
HM15211 0.04 mg/kg
|
Cohort 4 Active
n=7 Participants
HM15211 0.08 mg/kg
|
Cohort 5 Active
n=6 Participants
HM15211 0.12 mg/kg
|
Placebo
n=10 Participants
Placebo matched to the volume of the dose of HM15211
|
Total
n=41 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
41 Participants
n=8 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
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 14.34 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 11.06 • n=4 Participants
|
43.8 years
STANDARD_DEVIATION 13.53 • n=21 Participants
|
47.4 years
STANDARD_DEVIATION 6.55 • n=8 Participants
|
45.7 years
STANDARD_DEVIATION 11.38 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
10 participants
n=8 Participants
|
41 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 monthAn adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products
Outcome measures
| Measure |
Cohort 1 Active
n=6 Participants
HM15211 0.01 mg/kg
|
Cohort 2 Active
n=6 Participants
HM15211 0.02 mg/kg
|
Cohort 3 Active
n=6 Participants
HM15211 0.04 mg/kg
|
Cohort 4 Active
n=7 Participants
HM15211 0.08 mg/kg
|
Cohort 5 Active
n=6 Participants
HM15211 0.12 mg/kg
|
Placebo
n=10 Participants
Placebo matched to the volume of the dose of HM15211
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
Adverse Events
Cohort 1 Active
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 Active
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3 Active
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 Active
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 5 Active
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 Active
n=6 participants at risk
HM15211 0.01 mg/kg
|
Cohort 2 Active
n=6 participants at risk
HM15211 0.02 mg/kg
|
Cohort 3 Active
n=6 participants at risk
HM15211 0.04 mg/kg
|
Cohort 4 Active
n=7 participants at risk
HM15211 0.08 mg/kg
|
Cohort 5 Active
n=6 participants at risk
HM15211 0.12 mg/kg
|
Placebo
n=10 participants at risk
Placebo matched to the volume of the dose of HM15211
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
GI disorders
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
16.7%
1/6 • 1 month
|
57.1%
4/7 • 1 month
|
66.7%
4/6 • 1 month
|
10.0%
1/10 • 1 month
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/6 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/7 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Eye disorders
Eye disorders
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Infections and infestations
Infections and infestations
|
16.7%
1/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/7 • 1 month
|
33.3%
2/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/6 • 1 month
|
10.0%
1/10 • 1 month
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
14.3%
1/7 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue
|
16.7%
1/6 • 1 month
|
0.00%
0/6 • 1 month
|
33.3%
2/6 • 1 month
|
0.00%
0/7 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/6 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/6 • 1 month
|
57.1%
4/7 • 1 month
|
33.3%
2/6 • 1 month
|
20.0%
2/10 • 1 month
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/7 • 1 month
|
16.7%
1/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
|
16.7%
1/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/6 • 1 month
|
0.00%
0/10 • 1 month
|
|
General disorders
General disorders and administration
|
33.3%
2/6 • 1 month
|
16.7%
1/6 • 1 month
|
16.7%
1/6 • 1 month
|
28.6%
2/7 • 1 month
|
16.7%
1/6 • 1 month
|
40.0%
4/10 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place