Trial Outcomes & Findings for Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia (NCT NCT02771574)
NCT ID: NCT02771574
Last Updated: 2020-11-13
Results Overview
Nadir glucose at baseline and at Day 3 of treatment during oral glucose tolerance test (OGTT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Day 3 (time zero then every 30 minutes until 180 minutes or gylcemic rescue was required)
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc) twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
Lyo avexitide administered sc twice daily for 3 days
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Liquid avexitide (Liq avexitide) administered sc twice daily for 3 days
|
|---|---|---|---|---|---|
|
Lyo Avexitide Dose Level 1 (3 Days)
STARTED
|
3
|
0
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 1 (3 Days)
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 2 (3 Days)
STARTED
|
0
|
5
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 2 (3 Days)
COMPLETED
|
0
|
5
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 3 (3 Days)
STARTED
|
0
|
0
|
3
|
0
|
0
|
|
Lyo Avexitide Dose Level 3 (3 Days)
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
|
Lyo Avexitide Dose Level 3 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Lyo Avexitide Dose Level 4 (3 Days)
STARTED
|
0
|
0
|
0
|
3
|
0
|
|
Lyo Avexitide Dose Level 4 (3 Days)
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
|
Lyo Avexitide Dose Level 4 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Liq Avexitide (3 Days)
STARTED
|
0
|
0
|
0
|
0
|
5
|
|
Liq Avexitide (3 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
|
Liq Avexitide (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Baseline characteristics by cohort
| Measure |
Part A: Lyo Avexitide 0.05 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part B: Liq Avexitide 0.38 mg/kg
n=5 Participants
Liq avexitide administered sc twice daily for 3 days
|
Total
n=19 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 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
|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
48.0 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
46.7 years
STANDARD_DEVIATION 12.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 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
|
|
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
|
|
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
|
0 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 3 (time zero then every 30 minutes until 180 minutes or gylcemic rescue was required)Nadir glucose at baseline and at Day 3 of treatment during oral glucose tolerance test (OGTT).
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=6 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
n=5 Participants
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Nadir Glucose
Baseline
|
41 mg/dL
Standard Deviation 5
|
43 mg/dL
Standard Deviation 7
|
39 mg/dL
Standard Deviation 7
|
42 mg/dL
Standard Deviation 4
|
41 mg/dL
Standard Deviation 5
|
41 mg/dL
Standard Deviation 9
|
|
Nadir Glucose
Day 3
|
45 mg/dL
Standard Deviation 6
|
46 mg/dL
Standard Deviation 12
|
51 mg/dL
Standard Deviation 3
|
59 mg/dL
Standard Deviation 14
|
55 mg/dL
Standard Deviation 10
|
60 mg/dL
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline, Day 3Symptoms of hypoglycemia were assessed using the Edinburgh Hypoglycemia Symptom Scale that measures the intensity of 13 commonly experienced hypoglycemic symptoms, each severity graded on a 6-point Likert scale (0 = not present, 5 = severe). Scores are summed for a composite score ranging from 0 to 65, with higher scores corresponding to more severe hypoglycemia symptoms.
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=6 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
n=5 Participants
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Change in Composite Symptom Score as a Measure of Treatment Effect
Baseline
|
25 score on a scale
Standard Deviation 7
|
12 score on a scale
Standard Deviation 4
|
22 score on a scale
Standard Deviation 13
|
15 score on a scale
Standard Deviation 1
|
19 score on a scale
Standard Deviation 9
|
17 score on a scale
Standard Deviation 12
|
|
Change in Composite Symptom Score as a Measure of Treatment Effect
Day 3
|
25 score on a scale
Standard Deviation 11
|
12 score on a scale
Standard Deviation 9
|
15 score on a scale
Standard Deviation 11
|
7 score on a scale
Standard Deviation 3
|
11 score on a scale
Standard Deviation 8
|
9 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Day 3 (Predose)Pharmacokinetics of subcutaneous avexitide were assessed on Day 3 of twice daily dosing.
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics of Subcutaneous Avexitide: Plasma Concentration Prior to Dosing (Co)
|
11 ng/mL
Standard Deviation 7
|
16 ng/mL
Standard Deviation 11
|
4 ng/mL
Standard Deviation 2
|
71 ng/mL
Standard Deviation 62
|
204 ng/mL
Standard Deviation 91
|
—
|
SECONDARY outcome
Timeframe: Day 3 (Predose, and 60, 120, 150, 180, 210, 240, 270, 300, 330, 450, 720 minutes post-dose)Pharmacokinetics of subcutaneous avexitide were assessed on Day 3 of twice daily dosing.
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics of Subcutaneous Avexitide: Maximum Plasma Concentration (Cmax)
|
61 ng/mL
Standard Deviation 21
|
156 ng/mL
Standard Deviation 54
|
228 ng/mL
Standard Deviation 57
|
331 ng/mL
Standard Deviation 125
|
359 ng/mL
Standard Deviation 195
|
—
|
SECONDARY outcome
Timeframe: Day 3 (Predose, and 60, 120, 150, 180, 210, 240, 270, 300, 330, 450, 720 minutes post-dose)Pharmacokinetics of subcutaneous avexitide were assessed on Day 3 of twice daily dosing.
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics of Subcutaneous Avexitide: Time of Maximum Plasma Concentration (Tmax)
|
270 minutes
Standard Deviation 30
|
252 minutes
Standard Deviation 16
|
240 minutes
Standard Deviation 60
|
190 minutes
Standard Deviation 46
|
396 minutes
Standard Deviation 183
|
—
|
SECONDARY outcome
Timeframe: Day 3 (Predose, and 60, 120, 150, 180, 210, 240, 270, 300, 330, 450, 720 minutes post-dose)Pharmacokinetics of subcutaneous avexitide were assessed on Day 3 of twice daily dosing.
Outcome measures
| Measure |
Part A: Lyo Avexitide 0.5 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 Participants
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg and 0.46 mg/kg Groups
n=5 Participants
Lyo avexitide administered sc twice daily for 3 days
This reporting group is a pooled analysis of data from the Part A: Lyo avexitide 0.35 mg/kg and 0.46 mg/kg groups.
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics of Subcutaneous Avexitide: Area Under the Plasma Concentration Versus Time Curve (AUC)
|
21151 ng/mL*min
Standard Deviation 9877
|
51765 ng/mL*min
Standard Deviation 2134
|
77849 ng/mL*min
Standard Deviation 23670
|
129427 ng/mL*min
Standard Deviation 31325
|
147417 ng/mL*min
Standard Deviation 57722
|
—
|
Adverse Events
Part A: Lyo Avexitide 0.05 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Lyo Avexitide 0.15 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Lyo Avexitide 0.35 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Lyo Avexitide 0.46 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Lyo Avexitide 0.05 mg/kg
n=3 participants at risk
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.15 mg/kg
n=5 participants at risk
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.35 mg/kg
n=3 participants at risk
Lyo avexitide administered sc twice daily for 3 days
|
Part A: Lyo Avexitide 0.46 mg/kg
n=3 participants at risk
Lyo avexitide administered sc twice daily for 3 days
|
Part B: Liq Avexitide 0.38 (±0.03) mg/kg
n=5 participants at risk
Liq avexitide administered sc twice daily for 3 days
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Three (3) days per treatment period
|
0.00%
0/5 • Three (3) days per treatment period
|
66.7%
2/3 • Number of events 2 • Three (3) days per treatment period
|
33.3%
1/3 • Number of events 1 • Three (3) days per treatment period
|
0.00%
0/5 • Three (3) days per treatment period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Three (3) days per treatment period
|
0.00%
0/5 • Three (3) days per treatment period
|
0.00%
0/3 • Three (3) days per treatment period
|
66.7%
2/3 • Number of events 2 • Three (3) days per treatment period
|
0.00%
0/5 • Three (3) days per treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place