Nelson

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

This research evaluates the effects of ribupatide KAI-9531 given as a weekly subcutaneous injection compared to a placebo. It focuses on adults living with obesity or overweight who also have weight-related health issues but do not have diabetes. The study aims to understand how ribupatide influences body weight changes over time. Participants are randomly assigned to one of several groups receiving different doses of ribupatide once weekly or a matching placebo injection once weekly. The study is double-blind, so neither participants nor researchers know who receives the drug or placebo. Dosages range from Dose 1 to Dose 4, and the treatment period lasts up to 76 weeks. During the study, participants will have their body weight and various health indicators measured, including waist circumference, blood pressure, cholesterol levels, blood glucose, and quality of life related to weight. Safety is monitored by tracking adverse events and immune responses to the drug. The trial spans over approximately 76 weeks, with assessments at baseline and week 76 to evaluate changes and effects.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis AD. This Phase 1a1b randomized, double-blind, placebo-controlled study includes healthy participants and those with AD to better understand how TRB-061 behaves in the body and its effects. The study is divided into three parts to assess single and multiple doses in different groups. In Part 1, healthy participants receive a single ascending dose of TRB-061 or placebo and are followed for 12 weeks. Part 2 involves healthy participants receiving three doses of TRB-061 or placebo every four weeks over eight weeks, followed by a 10-week follow-up. Part 3 includes patients with moderate-to-severe AD randomized to receive either one of two doses of TRB-061 or placebo every four weeks for 12 weeks. Participants in Part 3 may opt into a crossover period where treatment assignments are switched for another 12 weeks, followed by a final follow-up until the end of the study. Participants will undergo safety assessments including monitoring of adverse events, pharmacokinetic blood tests, and clinical evaluations throughout the study and follow-up periods. Healthy participants are screened for general health and ECG abnormalities before enrollment, while AD patients must have a confirmed diagnosis and moderate-to-severe disease. Regular visits are scheduled for dosing and evaluations, and researchers will measure safety outcomes primarily by tracking adverse events from screening through follow-up. The study aims to complete by February 2028.

Researchers are evaluating the clinical efficacy and safety of OD-07656 in adults with moderately to severely active ulcerative colitis UC. The study also aims to assess whether OD-07656 can improve the benefits of vedolizumab when given after OD-07656 treatment. This Phase 2a study is sponsored by Odyssey Therapeutics and focuses on patients who have had an inadequate response or intolerance to various UC therapies. Participants will receive oral doses of OD-07656 twice daily in one of three dosing regimens, with some groups randomized to different doses. Following the OD-07656 treatment phase, subsequent vedolizumab therapy will be evaluated for its therapeutic effects. The study design includes an open-label part and a randomized part, each assessing treatment safety and efficacy over specified periods. During the study, participants will be monitored through regular assessments including the 3-component Modified Mayo Clinic Score at baseline and after 12 weeks of OD-07656 treatment. Researchers will track treatment-emergent adverse events and treatment discontinuations. Clinical remission rates will be evaluated both after OD-07656 treatment and following vedolizumab therapy up to 50 weeks. The total participation period and detailed monitoring schedules will be managed according to the study protocol.