Postbariatric HypoglycemiaPhase 2PREVENTNCT03373435
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
A Phase 2 study testing exendin 9-39 in people with Postbariatric Hypoglycemia, run by Eiger BioPharmaceuticals at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postbariatric Hypoglycemia
- What is being tested?
- exendin 9-39
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Mar 2018to 15 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of up to 40 kg/m2
- Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
- Diagnosis of PBH
- At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia
Who cannot join
- Other cause of endogenous hyperinsulinism other than PBH
- Metabolic or bariatric surgical procedure other than RYGB
- History of non-RYGB upper GI surgery
- Use of agents that may interfere with glucose metabolism
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado, Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Duke Early Phase Clinical Research
Durham, North Carolina, 27710
University of Wisconsin
Madison, Wisconsin, 53792
Stanford University
Palo Alto, California, 94304
About this study
Official title: A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
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).
Read the detailed description
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.
- Conditions
- Postbariatric Hypoglycemia
- Being tested
- exendin 9-39, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exendin 9-39Drug
Also called Avexitide
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
PlaceboOther
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | patients will receive two dose regimens of exendin 9-39 and one placebo Receives: Drug: exendin 9-39; Other: Placebo |
| Treatment Group 2 | Experimental | patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1) Receives: Drug: exendin 9-39; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose Nadir
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Measured: 3 hours following a liquid meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start19 Mar 2018
- Primary completion30 Jan 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postbariatric HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eiger BioPharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colleen Craig, MD, Study director, Eiger BioPharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373435
- Sponsor's protocol ID
- EIG-EXD-001
- Acronym
- PREVENT
- Status last verified
- Jun 2022
- First submitted
- 27 Nov 2017
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.
PubMed 33616643
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
- ClinicalTrials.gov ID
- NCT03373435
- Acronym / sponsor ID
- PREVENT / EIG-EXD-001
- Conditions
- Postbariatric Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eiger BioPharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: exendin 9-39, Other: Placebopatients will receive two dose regimens of exendin 9-39 and one placebo |
| Treatment Group 2 | Experimental | Drug: exendin 9-39, Other: Placebopatients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) of up to 40 kg/m2
- Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
- Diagnosis of PBH
- At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia
Key exclusion criteria (4 listed)
- Other cause of endogenous hyperinsulinism other than PBH
- Metabolic or bariatric surgical procedure other than RYGB
- History of non-RYGB upper GI surgery
- Use of agents that may interfere with glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exendin 9-39Also: AvexitideExendin 9-39 is a competitive antagonist of GLP-1 at its receptor. | Drug | Treatment Group 1, Treatment Group 2 |
| PlaceboPlacebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. | Other | Treatment Group 1, Treatment Group 2 |
Primary outcome
Postprandial Glucose Nadir
Time frame: 3 hours following a liquid meal
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33616643Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.
- Individual participant dataSharing planned: No
Related trials for Postbariatric Hypoglycemia
RecruitingPhase 2
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
Postbariatric Hypoglycemia
RecruitingObservational study
Cortisol and Obesity - A Vicious Cycle? Hypoglycemia After Bariatric Surgery - Association With Cortisol Metabolism?
Postbariatric Hypoglycemia
RecruitingPhase 3
Canakinumab for the Treatment of Postprandial Hypoglycemia
Postprandial Hypoglycemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Craig, MD study director
Eiger BioPharmaceuticals, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exendin 9-39 in people with Postbariatric Hypoglycemia, run by Eiger BioPharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Glucose Nadir (time frame: 3 hours following a liquid meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.