Phase 2 N=18 Randomized Single-blind Treatment

Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

Postbariatric Hypoglycemia

Bottom Line

View on ClinicalTrials.gov: NCT03373435 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Jun 2022

Primary outcome: Primary: Postprandial Glucose Nadir — 57.1; 59.2; 47.1 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: exendin 9-39 (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eiger BioPharmaceuticals
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Postprandial Glucose Nadir	57.1; 59.2; 47.1	—

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03373435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.