A Phase 2 interventional study of exendin 9-39 and Placebo in Postbariatric Hypoglycemia, sponsored by Eiger BioPharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Eiger BioPharmaceuticals · Phase 2, Interventional, and Treatment
This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.
Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.
Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 18 is below the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Eiger BioPharmaceuticals is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will receive two dose regimens of exendin 9-39 and one placebo
Drug: exendin 9-39 · Other: Placebo
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
Drug: exendin 9-39 · Other: Placebo
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Also known as: Avexitide
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Postprandial Glucose Nadir
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Time frame: 3 hours following a liquid meal
| Milestone | Treatment Group 1 | Treatment Group 2 |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
| Milestone | Treatment Group 1 | Treatment Group 2 |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
| Milestone | Treatment Group 1 | Treatment Group 2 |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
| mg/dL | Avexitide 30 mg BID | Avexitide 60 mg QD | Placebo |
|---|---|---|---|
| Postprandial Glucose Nadir | 57.1 ± 16.5 | 59.2 ± 16.1 | 47.1 ± 12.7 |
Collected over 3 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Avexitide 30 mg BID | 0/18 (0%) | 0/18 (0%) | 3/18 (16.7%) |
| Avexitide 60 mg QD | 0/18 (0%) | 1/18 (5.6%) | 9/18 (50%) |
| Placebo | 0/18 (0%) | 0/18 (0%) | 14/18 (77.8%) |
| Event | Avexitide 30 mg BID | Avexitide 60 mg QD | Placebo |
|---|---|---|---|
| presyncopeNervous system disorders | 0/18 | 1/18 | 0/18 |
| Event | Avexitide 30 mg BID | Avexitide 60 mg QD | Placebo |
|---|---|---|---|
| Injection site bruisingGeneral disorders | 0/18 | 1/18 | 7/18 |
| HeadacheNervous system disorders | 1/18 | 1/18 | 4/18 |
| NauseaGastrointestinal disorders | 2/18 | 3/18 | 4/18 |
| MigraineNervous system disorders | 0/18 | 2/18 | 0/18 |
| DizzinessNervous system disorders | 0/18 | 1/18 | 1/18 |
| Injection site painGeneral disorders | 0/18 | 1/18 | 1/18 |
| Age, Categorical(Participants) | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 10 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) | Total |
|---|---|---|---|
| Female | 8 | 10 | 18 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 10 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kilograms) | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) | Total |
|---|---|---|---|
| Mean | 81.6 ± 7.3 | 81.0 ± 16.1 | 81.23 ± 12.6 |
| Body Mass Index(kg/m^2) | Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD) | Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID) | Total |
|---|---|---|---|
| Mean | 30.0 ± 3.1 | 29.3 ± 4.9 | 29.6 ± 4.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jan 2019, 10 months.
Results were first posted in Jun 2022, 3 years 4 months after primary completion. A results delay was requested in Jan 2020.
Of 24 phase 2 interventional studies under Hypoglycemia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Avexitide
Eiger BioPharmaceuticals