Clinical trial

A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia

Name

52880

Description

The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.

Trial arms

Trial start

2021-06-21

Estimated PCD

2022-06-30

Trial end

2022-06-30

Status

Completed

Phase

Early phase I

Treatment

Avexitide

Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

Arms:

Avexitide 45 mg once daily then avexitide 90 mg twice daily, Avexitide 45 mg twice daily then avexitide 90 mg once daily

Size

Primary endpoint

Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)

Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Eligibility criteria

Inclusion Criteria: * History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening * History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record. * Body mass index (BMI) of up to 40 kg/m2 * If female, must not be breastfeeding and must have a negative urine pregnancy test result Exclusion Criteria: * Major surgery within 6 months before randomization. * History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia). * Use of agents that may interfere with glucose metabolism

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

Updated at

2023-06-09

1 organization

1 product

1 indication

Organization

Dr. Tracey McLaughlin

Product

Avexitide

Indication

Hyperinsulinemic Hypoglycemia