Neu Ulm

This research aims to evaluate participant satisfaction with subcutaneous SC administration of ocrelizumab in people with multiple sclerosis MS. Participants include those diagnosed with relapsing-remitting MS RMS or primary progressive MS PPMS according to the 2017 McDonald criteria. The study focuses on assessing satisfaction after 12 months of treatment using the Therapy Administration Satisfaction Questionnaire subcutaneous TASQ-SC. Participants will receive ocrelizumab as a subcutaneous injection for the first time as part of their routine MS therapy, following their physicians judgment and local guidelines. The study observes treatment satisfaction over a 12-month period without altering standard care. Treatment administration is monitored in accordance with usual clinical practice. Throughout the study, participants will complete satisfaction questionnaires at baseline, 6 months, and 12 months. Researchers will also measure neurofilament light chain NfL protein levels in serum at these timepoints and analyze their correlations with MS relapse, disability scale scores, previous treatments, and other factors. Safety is monitored by recording adverse events up to 12 months. The study involves regular assessments to understand the effects of ocrelizumab SC on patient satisfaction and biological markers over one year.

Researchers are evaluating AZD9550, a dual GCG and GLP-1 receptor agonist, alone and in combination with AZD6234, a selective androgen receptor antagonist SARA, for safety, tolerability, and effects in adults living with overweight or obesity, with or without type 2 diabetes mellitus T2DM. This Phase III randomized, single-blind, placebo-controlled study includes participants aged 18 to 65 or up to 75 years depending on study part and aims to understand how AZD9550 is processed in the body and its impact on metabolic parameters. The study involves multiple parts assessing AZD9550 given in various dosing schedules, including constant doses, weekly dose increases, and bi-weekly or monthly dose escalations over periods up to 28 weeks. Some parts evaluate AZD9550 alone, while another part examines co-administration of AZD9550 and AZD6234 in participants with T2DM. Placebo groups receive volume-matched injections to compare safety and tolerability. Dosing is administered via subcutaneous injections. Participants will attend study visits for safety assessments including monitoring adverse events, vital signs, ECGs, and laboratory tests from screening through up to 261 days. Pharmacokinetic and pharmacodynamic evaluations will measure drug levels and effects on glucose, lipids, body weight, and liver fat using tests such as continuous glucose monitoring, mixed meal tolerance tests, MRI, and MRS scans. The study also tracks antibody development to AZD9550 and monitors participant adherence and tolerability throughout the study duration.

Researchers are evaluating the safety, tolerability, immune response, pharmacokinetics, and pharmacodynamics of single ascending doses of M5542 administered under the skin in healthy adult volunteers. This early-phase trial aims to gather important information about how the body handles M5542 and how the immune system reacts to it. Participants will receive a single dose of either M5542 or a matching placebo by subcutaneous injection on the first day of the study. The doses will increase in a stepwise fashion across groups to assess different levels. The study design includes randomized assignment and quadruple masking to ensure unbiased results. During the study, participants will be monitored up to 85 days for any treatment-related adverse events, abnormal lab tests, heart function via ECG, and vital signs. Blood samples will be collected at various times up to about 56 days after dosing to measure drug levels and check for antibodies against M5542. Overall participation lasts several weeks with close safety and immune response monitoring throughout.