13 completed, 1 withdrawn. 10 Phase 2, 5 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 9, Withdrawn 1 |
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 1 | Withdrawn 1 |
Follow aldafermin: new trials by email Literature Review of aldafermin trials Research Report on aldafermin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis. aldafermin, Placebo - Primary Sclerosing Cholangitis | Phase 2 / Phase 3 | Withdrawn | NGM Biopharmaceuticals, Inc | 2024-10-21 | 2025-05-07 | |
| Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM) Aldafermin, Placebo - Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea | Phase 2 | Completed | Michael Camilleri, MD | 30 | 2021-12-01 | 2023-10-12 |
| Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects Aldafermin - Healthy Male | Phase 1 | Completed | NGM Biopharmaceuticals, Inc | 36 | 2021-04-13 | 2022-01-31 |
| Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function Aldafermin - Impaired Hepatic Function | Phase 1 | Completed | NGM Biopharmaceuticals, Inc | 36 | 2021-04-01 | 2022-01-19 |
| Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) aldafermin, Placebo - Compensated Cirrhosis, Nonalcoholic Steatohepatitis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 160 | 2020-03-23 | 2025-03-26 |
| Study of Aldafermin (NGM282) in Participants With Impaired Renal Function Aldafermin (NGM282) - Impaired Renal Function | Phase 1 | Completed | NGM Biopharmaceuticals, Inc | 48 | 2019-11-08 | 2020-04-27 |
| 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) NGM282, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 171 | 2019-05-16 | 2025-07-03 |
| A Study of NGM282 in Patients With Primary Sclerosing Cholangitis NGM282, Placebo - Primary Sclerosing Cholangitis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 62 | 2016-03-01 | 2025-06-17 |
| Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals NGM282, Placebo - Functional Constipation | Phase 1 / Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 31 | 2015-12-01 | 2018-03-30 |
| Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) NGM282, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 254 | 2015-07-31 | 2025-07-23 |
| Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis NGM282 - Primary Biliary Cirrhosis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 36 | 2014-05-01 | 2017-03-28 |
| Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis NGM282, Placebo - Primary Biliary Cirrhosis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 45 | 2014-02-01 | 2017-03-28 |
| Phase 2 Study of NGM282 in Patients With Type 2 Diabetes NGM282, Placebo - Diabetes Mellitus | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 81 | 2013-09-01 | 2015-11-17 |
| Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants NGM282, Placebo - Diabetes Mellitus | Phase 1 | Completed | NGM Biopharmaceuticals, Inc | 119 | 2013-01-01 | 2013-12-31 |
Non-alcoholic Fatty Liver Disease (3) · Cholangitis, Sclerosing (2) · Diabetes Mellitus (2) · Liver Cirrhosis, Biliary (2) · Renal Insufficiency (1)
NGM Biopharmaceuticals, Inc (13) · Michael Camilleri, MD (1)
United States (11) · Australia (6) · Puerto Rico (3) · France (2) · New Zealand (2) · United Kingdom (2) · Belgium (1) · Germany (1) · Hong Kong (1) · Netherlands (1) · Poland (1)
Stephen J Rossi, PharmD (4) · Alex M DePaoli, MD (2) · Michael Camilleri, M.D. (1)
PMID 33898959, PMID 29519502, PMID 30862680, PMID 32781086, PMID 32794259, PMID 35325622, PMID 36318027, PMID 37732990, PMID 39326675
2015 (1)