The purpose to evaluate whether outcomes in pregnant individuals with gestational diabetes randomized to metformin are not inferior to those in pregnant individuals randomized to insulin for the composite adverse neonatal outcome. Participants will be randomized to treatment with either insulin or metformin. Study visits include monthly check in visits, 6 week postpartum visit, and 2 year postpartum visit with mother and child.

This is a randomized, multicenter, double-blind, phase 2/3 study to evaluate the efficacy and safety of inebilizumab in participants with active autoimmune hepatitis (AIH) who are inadequately responding and/or are intolerant to standard of care (SOC). The study consists of 2 parts, a phase 2 dose confirmation and safety part (Part 1) and an efficacy evaluating phase 3 (Part 2). The combined data from both Part 1 and Part 2 will be included in the primary analysis. The target population includes adults who have a definitive diagnosis of AIH and have either inadequate response to at least 9 months of SOC or is intolerant to SOC within 6 months of screening. The Primary objective for Part 1 is to evaluate the safety and tolerability of inebilizumab in participants with AIH. The Primary objective of Part 2 is to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH.