Product
ORMD-0801
Aliases
Oral Insulin, ORMD-0801 QD
5 clinical trials
4 indications
Indication
Nonalcoholic SteatohepatitisIndication
Diabetes MellitusIndication
Type 2Indication
Type 2 Diabetes MellitusClinical trial
An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH)Status: Completed, Estimated PCD: 2020-03-01
Clinical trial
A Randomized, Double Blind, Phase 2b Study to Evaluate the Effect of ORMD-0801 Compared to Placebo on Endogenous Glucose Production in Patients With Type 2 Diabetes MellitusStatus: Completed, Estimated PCD: 2022-06-07
Clinical trial
A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With T2DM With Inadequate Glycemic Control on 1, 2 or 3 Oral Glucose-lowering Agents.Status: Terminated, Estimated PCD: 2023-01-13
Clinical trial
A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.Status: Terminated, Estimated PCD: 2023-01-13
Clinical trial
A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral TherapyStatus: Completed, Estimated PCD: 2019-10-21