TABLE 2.

Recent and ongoing clinical trials (phase 2 or higher) with FGF19 analogues.

Substance	Trial phase	Study population	Endpoints	Results	Status*	Reference
NGM282	IIb	PBC (No dACLD)	Primary: change plasma ALP at W12 (randomised; three doses, no placebo) Secondary: change bilirubin, AST, ALT, GGT	No results published	Completed	NCT02135536
NGM282	II	PBC (No dACLD)	Primary: change plasma ALP at W4 (randomised; vs placebo) Secondary: change plasma bilirubin	No results published	Completed	NCT02026401
NGM282	II	PSC (No dACLD)	Primary: change plasma ALP at W12 (randomised; vs placebo) Secondary: AST, ALT	No significant reduction of ALP levels Reduction of C4 and fibrosis blood markers	Completed	NCT02704364 160
NGM282	II	NASH (No ACLD)	Primary: absolute hepatic fat content at W12 (randomised; vs placebo) Secondary: relative hepatic fat content	5% reduction of hepatic fat fraction in 74%–70% with NGM282% vs 7% in placebo group AEs more frequent than in placebo group (injection site reactions, diarrhoea, abdominal pain, nausea)	Completed	NCT02443116 161 , 162
NGM282	II	NASH (cACLD, F4)	Primary: fibrosis improvement ≥1 stage without NASH worsening, safety at W48 (randomised; vs placebo)	No results published	Recruiting	ALPINE 4 NCT04210245
NGM282	II	DM type 2	Primary: fasting plasma glucose at W4 (randomised; vs placebo) Secondary: HbA1c, lipids	No impact on hyperglycemia NGM282 reduced AST, ALT and C4 levels FGF19 increased by bariatric RYGB surgery	Completed	NCT01943045 193

Abbreviations: AE, adverse event; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; c/dACLD, compensated/decompensated advanced chronic liver disease; DM, diabetes mellitus; FGF19, fibroblast growth factor 19; GGT, gamma‐glutamyl transferase; NASH, non‐alcoholic steatohepatitis; PBC, primary biliary cholangitis; PSC, primary sclerosing cholangitis; RYGB, Roux‐en‐Y gastric bypass; W, week.

*Trial status was obtained from ‘https://ClinicalTrials.gov’.