Effects of NGM282, an FGF19 variant, on colonic transit and bowel function in functional constipation: a randomized phase 2 trial

Autor: Paula Carlson, Michael Camilleri, Ibironke Oduyebo, Stephen Joseph Rossi, Duane Burton, Michael Ryks, Disha Khemani, Alan J. Lueke, Irene Busciglio, Sara Linker Nord, Leslie J. Donato, Alfred D. Nelson, Deborah Rhoten, Kathline H. Kim, Alan R. Zinsmeister
Rok vydání: 2017
Předmět:
0301 basic medicine
Adult
Male
medicine.medical_specialty
medicine.drug_class
Injections
Subcutaneous

Appetite
Placebo
Gastroenterology
Polymorphism
Single Nucleotide

Receptors
G-Protein-Coupled

Bile Acids and Salts
03 medical and health sciences
Feces
0302 clinical medicine
Internal medicine
Injection site reaction
medicine
Humans
Receptor
Fibroblast Growth Factor
Type 4

Defecation
Gastrointestinal Transit
Klotho Proteins
Hepatology
Gastric emptying
Bile acid
Dose-Response Relationship
Drug

business.industry
Membrane Proteins
FGF19
Middle Aged
medicine.disease
Recombinant Proteins
Injection Site Reaction
Fibroblast Growth Factors
Diarrhea
030104 developmental biology
Treatment Outcome
Liver
Functional constipation
030211 gastroenterology & hepatology
Female
medicine.symptom
business
Gastrointestinal Motility
Constipation
Zdroj: The American journal of gastroenterology. 113(5)
ISSN: 1572-0241
Popis: NGM282 is an analog of fibroblast growth factor 19 (FGF19), a potent inhibitor of bile acid (BA) synthesis in animals and humans. In phase 2 trials in type 2 diabetes and primary biliary cholangitis, NGM282 was associated with dose-related abdominal cramping and diarrhea. We aimed to examine effects of NGM282 on colonic transit, stool frequency and consistency, hepatic BA synthesis (fasting serum C4), fecal fat, and BA in functional constipation (FC). Two-dose NGM282 (1 and 6 mg, subcutaneously daily), parallel-group, randomized, placebo-controlled, 14-day study in patients with FC (Rome III criteria) and baseline colonic transit 24 h geometric center (GC)
Databáze: OpenAIRE