Trial Outcomes & Findings for A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD (NCT NCT03744182)
NCT ID: NCT03744182
Last Updated: 2025-01-27
Results Overview
Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation \[cholelithiasis\] were managed following a separate AE guidance document
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-01-27
Participant Flow
Date of first enrollment was November 1st, 2018. Last subject was enrolled on March 3rd, 2020.
Participant milestones
| Measure |
0.01 mg/kg HM15211
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
0.01 mg/kg HM15211
|
0.02 mg/kg HM15211
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.02 mg/kg HM15211
|
0.04 mg/kg HM15211
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.04 mg/kg HM15211
|
0.06 mg/kg HM15211
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.06 mg/kg HM15211
|
0.08 mg/kg HM15211
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.08 mg/kg HM15211
|
Placebo
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
12
|
9
|
9
|
17
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
9
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
Baseline characteristics by cohort
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
Total
n=66 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
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
66 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
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
1 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
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race: Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
17 participants
n=8 Participants
|
66 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksCardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation \[cholelithiasis\] were managed following a separate AE guidance document
Outcome measures
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
7 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksObserved Values and Change from Baseline in Renal Function of Urea Nitrogen
Outcome measures
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Incidence of Clinical Renal Function Lab Abnormalities
|
-1.111 mmol/L
Standard Deviation 0.7240
|
-0.238 mmol/L
Standard Deviation 0.7142
|
0.036 mmol/L
Standard Deviation 1.1350
|
-0.754 mmol/L
Standard Deviation 0.7242
|
-0.893 mmol/L
Standard Deviation 0.5414
|
0.190 mmol/L
Standard Deviation 1.4962
|
PRIMARY outcome
Timeframe: baseline and 12 weeksChange from baseline in vital signs (Systolic Blood)
Outcome measures
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Vital Signs
|
7.2 mmHg
Standard Deviation 14.96
|
7.1 mmHg
Standard Deviation 12.64
|
-0.7 mmHg
Standard Deviation 13.33
|
-3.3 mmHg
Standard Deviation 8.67
|
-4.5 mmHg
Standard Deviation 18.80
|
2.2 mmHg
Standard Deviation 12.27
|
PRIMARY outcome
Timeframe: baseline and 12 weeksChange from baseline in 12-lead ECG; the primary ECG endpoint was QTcF
Outcome measures
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
12-lead ECG
|
4.2 milliseconds
Standard Deviation 7.79
|
1.3 milliseconds
Standard Deviation 9.51
|
-1.3 milliseconds
Standard Deviation 7.14
|
0 milliseconds
Standard Deviation 3.59
|
-2.2 milliseconds
Standard Deviation 9.02
|
2.5 milliseconds
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: baseline and 12 weeksChange of Body Mass Index from baseline to 12 weeks after IP injection
Outcome measures
| Measure |
HM15211 0.01 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.02 mg/kg
n=10 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.04 mg/kg
n=12 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.06 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
HM15211 0.08 mg/kg
n=9 Participants
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
|
Placebo
n=17 Participants
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Body Mass Index
|
35.46 kg/m2
Standard Deviation 3.835
|
32.91 kg/m2
Standard Deviation 2.936
|
37.86 kg/m2
Standard Deviation 6.254
|
40.13 kg/m2
Standard Deviation 7.113
|
35.74 kg/m2
Standard Deviation 3.796
|
34.61 kg/m2
Standard Deviation 3.521
|
Adverse Events
0.01 mg/kg HM15211
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.02 mg/kg HM15211
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
0.04 mg/kg HM15211
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
0.06 mg/kg HM15211
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.08 mg/kg HM15211
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.01 mg/kg HM15211
n=9 participants at risk
HM15211: A sterile solution of HM15211 contained in pre-filled syringes
0.01 mg/kg HM15211
|
0.02 mg/kg HM15211
n=10 participants at risk
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.02 mg/kg HM15211
|
0.04 mg/kg HM15211
n=12 participants at risk
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.04 mg/kg HM15211
|
0.06 mg/kg HM15211
n=9 participants at risk
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.06 mg/kg HM15211
|
0.08 mg/kg HM15211
n=9 participants at risk
HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.08 mg/kg HM15211
|
Placebo
n=17 participants at risk
Placebo of HM15211: A sterile, matching solution in pre-filled syringes
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
16.7%
2/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
33.3%
3/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
33.3%
3/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
5.9%
1/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
5.9%
1/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
General disorders
Chest pain
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
5.9%
1/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
General disorders
Injection site erythema
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
20.0%
2/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
8.3%
1/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
44.4%
4/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
16.7%
2/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
17.6%
3/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Investigations
Glucose urine present
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
16.7%
2/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
5.9%
1/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
10.0%
1/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
8.3%
1/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
22.2%
2/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
11.1%
1/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
5.9%
1/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/10 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
8.3%
1/12 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/9 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
0.00%
0/17 • 23 weeks
All AEs were collected over 23 weeks in safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place