Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
NCT04857606 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2023-11-07
Summary
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).
Conditions
- Non-alcoholic Fatty Liver Disease
Interventions
- DRUG
-
AMG 609
Single dose of AMG 609 administered as a subcutaneous injection.
- DRUG
-
Single dose of placebo administered as a subcutaneous injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-24
- Primary Completion
- 2023-07-19
- Completion
- 2023-07-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
NCT03437720 ·Status: WITHDRAWN ·Phase: PHASE2
-
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT02912260 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
NCT03998514 ·Status: COMPLETED ·Phase: PHASE1
-
Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis
NCT02029586 ·Status: TERMINATED ·Phase: PHASE2
-
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT05648214 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
NCT03486899 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT05809934 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
NCT05857644 ·Status: COMPLETED ·Phase: PHASE1
-
Reducing Non-Alcoholic Steatohepatitis
NCT06519448 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
NCT07214870 ·Status: RECRUITING ·Phase: PHASE1
-
a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease(NAFLD)
NCT07128797 ·Status: RECRUITING ·Phase: PHASE1
-
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
NCT05692492 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT03400163 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
NCT03486912 ·Status: COMPLETED ·Phase: PHASE2
-
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
NCT05006885 ·Status: COMPLETED ·Phase: PHASE1
-
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT05395481 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
NCT05842512 ·Status: RECRUITING ·Phase: PHASE2
-
Effect of Empagliflozin on Liver Fat in Non-diabetic Patients
NCT04642261 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
NCT03468556 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
NCT00492700 ·Status: COMPLETED ·Phase: PHASE2
-
Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males
NCT06308861 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT02413372 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate MET642 in Patients With NASH
NCT04773964 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
NCT05281328 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Phase 2a Study of HPG1860 in Subjects With NASH
NCT05338034 ·Status: UNKNOWN ·Phase: PHASE2