Trial Outcomes & Findings for Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia (NCT NCT03373435)
NCT ID: NCT03373435
Last Updated: 2022-07-18
Results Overview
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
3 hours following a liquid meal
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
Treatment Group 1
Placebo first, then exendin 9-39 30 mg BID, then exendin 9-39 60 mg QD
exendin 9-39: Exendin 9-39 is a competitive antagonist of glucagon-like peptide-1 (GLP-1) at its receptor.
Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
Treatment Group 2
Placebo first, then exendin 9-39 60 mg QD, then exendin 9-39 30 mg BID
exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
|---|---|---|
|
Treatment Period 1 (14 Days)
STARTED
|
8
|
10
|
|
Treatment Period 1 (14 Days)
COMPLETED
|
8
|
10
|
|
Treatment Period 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (14 Days)
STARTED
|
8
|
10
|
|
Treatment Period 2 (14 Days)
COMPLETED
|
8
|
10
|
|
Treatment Period 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 3 (14 Days)
STARTED
|
8
|
10
|
|
Treatment Period 3 (14 Days)
COMPLETED
|
8
|
10
|
|
Treatment Period 3 (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Baseline characteristics by cohort
| Measure |
Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD)
n=8 Participants
Placebo, exendin 9-39 30 mg BID, exendin 9-39 60 mg QD
exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID)
n=10 Participants
Placebo, exendin 9-39 60 mg QD, exendin 9-39 30 mg BID
exendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Placebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
81.6 kilograms
STANDARD_DEVIATION 7.3 • n=5 Participants
|
81.0 kilograms
STANDARD_DEVIATION 16.1 • n=7 Participants
|
81.23 kilograms
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Body Mass Index
|
30.0 kg/m^2
STANDARD_DEVIATION 3.1 • n=5 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours following a liquid mealPopulation: Analysis population are both treatment group 1 and treatment group 2. One participant was excluded from the efficacy analysis due to major protocol deviation.
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Outcome measures
| Measure |
Avexitide 30 mg BID
n=17 Participants
patients (treatment group 1 + treatment 2) received 30 mg twice a day
|
Avexitide 60 mg QD
n=17 Participants
patients (treatment group 1 + treatment group 2)) receive 60 mg once a day.
|
Placebo
n=17 Participants
Patients received placebo in treatment period 1 (initial 14 days) in the study.
|
|---|---|---|---|
|
Postprandial Glucose Nadir
|
57.1 mg/dL
Standard Deviation 16.5
|
59.2 mg/dL
Standard Deviation 16.1
|
47.1 mg/dL
Standard Deviation 12.7
|
Adverse Events
Avexitide 30 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Avexitide 60 mg QD
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avexitide 30 mg BID
n=18 participants at risk
patients (treatment group 1 + treatment 2) received 30 mg twice a day
|
Avexitide 60 mg QD
n=18 participants at risk
patients (treatment group 1 + treatment group 2)) received 60 mg once a day.
|
Placebo
n=18 participants at risk
Patients received placebo in treatment period 1 (initial 14 days) in the study.
|
|---|---|---|---|
|
Nervous system disorders
presyncope
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
Other adverse events
| Measure |
Avexitide 30 mg BID
n=18 participants at risk
patients (treatment group 1 + treatment 2) received 30 mg twice a day
|
Avexitide 60 mg QD
n=18 participants at risk
patients (treatment group 1 + treatment group 2)) received 60 mg once a day.
|
Placebo
n=18 participants at risk
Patients received placebo in treatment period 1 (initial 14 days) in the study.
|
|---|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
38.9%
7/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
22.2%
4/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
16.7%
3/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
22.2%
4/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
|
General disorders
Injection site pain
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
5.6%
1/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
11.1%
2/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
0.00%
0/18 • 3 Months
Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.
|
Additional Information
Senior VP, Clinical Development
Eiger BioPharmaceuticals, Inc.
Phone: 1-650-272-6138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place