- |||||||||| aldafermin (NGM282) / NGM Biopharma
Trial completion date, Trial primary completion date: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3) (clinicaltrials.gov) - Nov 23, 2020 P2b, N=152, Active, not recruiting, Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Jun 2021
- |||||||||| aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] LIPID MANAGEMENT IN A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALDAFERMIN (NGM282) () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1678; ROS can safely manage the cholesterol increase seen in NASH patients treated with aldafermin, producing an overall favorable lipid, lipoprotein and ASCVD profile. Given the recent revisions in society guidelines, lipid management goals based on the ASCVD risk score, rather than a particular LDL-C target value, should be implemented for future studies.
- |||||||||| NGM621 Intravitreal / NGM Biopharma
Trial completion, Enrollment change, Trial completion date: Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - Sep 30, 2020 P1, N=15, Completed, These results are consistent with our previous 12-week studies, demonstrating durable response and accumulation of histological benefit over time. Active, not recruiting --> Completed | N=24 --> 15 | Trial completion date: Dec 2020 --> May 2020
- |||||||||| aldafermin (NGM282) / NGM Biopharma
Biomarker, Clinical, P2 data, Journal: Effect of NGM282, a FGF19 analogue, in Primary Sclerosing Cholangitis: a Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. (Pubmed Central) - Sep 24, 2020 Active, not recruiting --> Completed | N=24 --> 15 | Trial completion date: Dec 2020 --> May 2020 In patients with PSC, NGM282 potently inhibited bile acid synthesis and decreased fibrosis markers, without significantly affecting ALP levels.
- |||||||||| aldafermin (NGM282) / NGM Biopharma
Enrollment closed: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3) (clinicaltrials.gov) - Sep 22, 2020 P2b, N=152, Active, not recruiting, Co-administration of rosuvastatin with NGM282 may be a reasonable strategy to optimize cardiovascular risk profile in patients with NASH. Recruiting --> Active, not recruiting
- |||||||||| aldafermin (NGM282) / NGM Biopharma
Trial completion, Trial completion date, Trial primary completion date: Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Sep 10, 2020 P2, N=254, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Sep 2019 --> Jan 2020 | Trial primary completion date: Sep 2019 --> Dec 2019
- |||||||||| PF-05231023 / Pfizer, LY2405319 / Eli Lilly, aldafermin (NGM282) / NGM Biopharmaceuticals
Clinical, Journal: Fibroblast growth factors in control of lipid metabolism: from biological function to clinical application. (Pubmed Central) - Jun 10, 2020 Clinical trials with FGF-based drugs report beneficial effects in lipid and bile acid metabolism, with clinical improvements in dyslipidemia, steatosis, weight loss, and liver damage. In contrast, glucose-lowering effects, as observed in preclinical models, are currently lacking.
- |||||||||| aldafermin (NGM282) / NGM Biopharmaceuticals
[VIRTUAL] Correlation of serum bile acids and pruritus with aldafermin (NGM282) therapy in patients with primary sclerosing cholangitis (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1058; Given that liver fibrosis progression and HCC growth are associated with matrix stiffness and cross-linking of collagens, these results may support an anti-tumor activity, in addition to the anti-fibrotic activity, of aldafermin in chronic liver disease. Reductions in serum GCA and GCDCA correlated with reductions in 5D-itch score in PSC patients treated with aldafermin, suggesting that these BA species may serve as markers of pruritus response to aldafermin treatment.
- |||||||||| NGM395 / NGM Biopharma
Enrollment open: Study of NGM395 in Adult Participants (clinicaltrials.gov) - Mar 23, 2020 P1, N=80, Recruiting, Recruiting --> Completed | Trial completion date: Jun 2020 --> Dec 2019 Not yet recruiting --> Recruiting
- |||||||||| NGM621 Intravitreal / NGM Biopharma
Enrollment closed: Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - Mar 4, 2020 P1, N=24, Active, not recruiting, NGM621 is currently being evaluated in a Phase 1 clinical trial for safety and tolerability in patients with GA. Recruiting --> Active, not recruiting
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