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

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).

Timeline

Start

2018-03-19

Primary completion

2019-01-30

Completion

2019-03-15

Outcome

Met primary endpoint

paper Compared with placebo, avexitide 30 mg twice daily and 60 mg once daily raised the glucose nadir by 21% (P = .001) and 26% (P = .0002) PMID 33616643 ↗

paper and lowered the insulin peak by 23% (P = .029) and 21% (P = .042), corresponding to 50% and 75% fewer participants requiring rescue during MMTT, respectively. PMID 33616643 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avexitide	Peptide	30 mg	Subcutaneous
Subject	Avexitide	Peptide	60 mg	Subcutaneous

Indications