Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
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ClinicalTrials.gov Identifier: NCT02771574 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Results First Posted : August 14, 2020
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post Bariatric Hypoglycemia | Drug: Lyo avexitide Drug: Liq avexitide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Multi-Ascending Dose Trial to Assess the Efficacy, Tolerability and Pharmacokinetic Profile of Exendin (9-39) in Patients With Post-bariatric Hyperinsulinemic Hypoglycemia |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A: Lyo avexitide 0.05 mg/kg
Participants will receive lyophilized avexitide (Lyo avexitide) twice daily for 3 days
|
Drug: Lyo avexitide
Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)
Other Name: Exendin (9-39) |
Experimental: Part A: Lyo avexitide 0.15 mg/kg
Participants will receive Lyo avexitide twice daily for 3 days
|
Drug: Lyo avexitide
Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)
Other Name: Exendin (9-39) |
Experimental: Part A: Lyo avexitide 0.35 mg/kg
Participants will receive Lyo avexitide twice daily for 3 days
|
Drug: Lyo avexitide
Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)
Other Name: Exendin (9-39) |
Experimental: Part A: Lyo avexitide 0.46 mg/kg
Participants will receive Lyo avexitide twice daily for 3 days
|
Drug: Lyo avexitide
Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)
Other Name: Exendin (9-39) |
Experimental: Part B: Liq avexitide 0.38 (±0.03) mg/kg
Participants will receive liquid avexitide (Liq avexitide) twice daily for 3 days
|
Drug: Liq avexitide
Liquid avexitide (Liq avexitide) administered subcutaneously (sc)
Other Name: Exendin (9-39) |
- Nadir Glucose [ Time Frame: 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).
- Change in Composite Symptom Score as a Measure of Treatment Effect [ Time Frame: Baseline, Day 3 ]Symptoms 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.
- Pharmacokinetics of Subcutaneous Avexitide: Plasma Concentration Prior to Dosing (Co) [ Time Frame: Day 3 (Predose) ]Pharmacokinetics of subcutaneous avexitide were assessed on Day 3 of twice daily dosing.
- Pharmacokinetics of Subcutaneous Avexitide: Maximum Plasma Concentration (Cmax) [ Time Frame: 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.
- Pharmacokinetics of Subcutaneous Avexitide: Time of Maximum Plasma Concentration (Tmax) [ Time Frame: 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.
- Pharmacokinetics of Subcutaneous Avexitide: Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Post-bariatric surgery more than 6 months prior to signing the informed consent
- Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
- Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.
Exclusion Criteria:
- Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
- Participation in any clinical investigation within 4 weeks prior to dosing
- History of or current insulinoma
- Active infection or significant acute illness within 2 weeks prior to dosing
- Female patients who are pregnant or lactating
- Women of childbearing potential and not utilizing effective contraceptive methods
- Inadequate end organ function

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771574
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Marilyn Tan, MD | Clinical Assistant Professor |
Documents provided by Tracey McLaughlin, Stanford University:
Responsible Party: | Tracey McLaughlin, Associate Professor of Medicine (Endocrinology), Stanford University |
ClinicalTrials.gov Identifier: | NCT02771574 |
Other Study ID Numbers: |
36673 |
First Posted: | May 13, 2016 Key Record Dates |
Results First Posted: | August 14, 2020 |
Last Update Posted: | November 13, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bariatric surgery complications Glucose Metabolism Disorders Exendin (9-39) GLP-1 |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |