Anniston

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the safety, tolerability, and how the body processes LY4213663 in healthy adults and adults with rheumatoid arthritis RA. This Phase 1 study aims to understand potential side effects and how the drug behaves when given by injection under the skin or into a vein. The study includes both healthy participants and those diagnosed with RA, with a focus on basic science aspects of the treatment. The study involves several parts single-ascending doses a gradually increasing dose and multiple-ascending doses of LY4213663 or placebo given either subcutaneously or intravenously in healthy participants. In participants with RA, multiple doses of LY4213663 are given by these two methods. The study design includes randomized assignments to drug or placebo groups for the healthy participant parts, while the RA participant parts are open-label. The entire study lasts about 33 weeks, excluding screening. Participants will have blood tests to check drug levels and effects, as well as monitoring for any serious side effects related to the drug. Researchers will assess safety throughout the study by tracking adverse events. The study measures how much LY4213663 is in the blood over time and its maximum concentration. Participants will attend regular visits for dosing and assessments during the study period, which runs from screening through to the last follow-up around 33 weeks after dosing begins.

Researchers are evaluating a new mRNA vaccine that combines protection against both seasonal flu and COVID-19 in healthy adults aged 65 to 85 years. This early-stage Phase 1 study aims to assess the safety and immune response of this investigational vaccine compared to standard licensed flu and COVID-19 vaccines. The study is focused on measuring side effects and how well the vaccine builds protection against both infections. Participants will receive a single intramuscular injection of either one of three dose levels of the investigational mRNA combination vaccine, a licensed seasonal flu vaccine, or a licensed COVID-19 vaccine. The study groups are randomized and observer-blind. The investigational vaccine is given as a single dose, with three different dosage levels being tested sequentially for safety and immune response. During the study, participants will be monitored for side effects from the day of vaccination through several time points up to 181 days. Blood samples will be collected at specified intervals to evaluate immune responses against flu and COVID-19. The main measures include the number of participants experiencing laboratory abnormalities and adverse events, as well as immune protection markers such as antibody levels and seroconversion rates. The total participation spans from vaccination day through about six months of follow-up.

Researchers are studying adults with Systemic Lupus Erythematosus SLE or Rheumatoid Arthritis RA, chronic autoimmune and inflammatory diseases, to assess how the drug ABBV-519 behaves in the body, its effects, and safety. This Phase 1 study focuses on participants with moderate SLE or RA and aims to understand the pharmacokinetics, pharmacodynamics, and safety profile of ABBV-519. Participants will receive a single dose of ABBV-519 either by intravenous infusion or subcutaneous injection. The study includes five groups receiving different doses of the drug. The total study duration is approximately 425 days, which includes a 60-day screening period, a 1-day treatment period, and a 52-week follow-up period to monitor participants after treatment. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in B cells, drug concentration in blood over time, detection of anti-drug antibodies, and adverse events. The long follow-up period allows careful monitoring of participants health and the drugs effects.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of AZD5492, a drug given by subcutaneous injection, in adults diagnosed with Systemic Lupus Erythematosus SLE, Idiopathic Inflammatory Myopathies IIM, or Rheumatoid Arthritis RA. This open-label, multi-center Phase I study is designed to understand how the drug behaves in the body and its safety profile in these autoimmune conditions. The study is sponsored by AstraZeneca and includes adult participants between 18 and 70 years old. The study has two parts. In Part 1, participants with SLE receive a single dose of AZD5492 at ascending dose levels to evaluate safety and dosing. Up to five dose levels are planned, with the possibility of additional doses based on emerging data. In Part 2, participants with SLE not in Part 1, IIM, or RA receive two doses of AZD5492 seven days apart in a step-up dosing pattern, starting with a priming dose followed by an escalated target dose. Study visits are scheduled at screening, several early days after dosing, and then periodically through Day 180. Participants will be involved in visits for screening, dosing, and follow-up assessments lasting at least 180 days after dosing, with possible additional visits up to 12 months from study start. Researchers will monitor safety by tracking treatment-emergent adverse events, dose-limiting toxicities, laboratory and vital sign abnormalities, and heart monitoring via ECG. They will also measure drug levels in the blood, immune responses, and changes in B-cell counts to better understand how AZD5492 works and its effects over time.

Researchers are evaluating an experimental drug called alirocumab for adults with hypercholesterolemia, a condition characterized by high blood cholesterol levels. This Phase 2 study aims to assess the safety and effectiveness of alirocumab when given weekly. The trial also explores other important questions, such as potential side effects and how the drug behaves in the blood over time. Participants will be randomly assigned to one of four study groups receiving different doses of alirocumab, ranging from low to high doses, including a control dose. The drug is administered according to the study protocol on a weekly basis. The study monitors participants for up to 20 weeks to observe the effects and drug levels in the body. During the study, participants will have regular blood tests to measure cholesterol levels and the concentration of alirocumab in their serum. Researchers will track changes in LDL cholesterol, total cholesterol, HDL cholesterol, triglycerides, and other markers through 12 weeks, as well as monitor any treatment-emergent side effects during the 20 weeks. The total study duration lasts until February 2027, with close safety and pharmacokinetic follow-up.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults with excess body weight. This phase 3 clinical trial compares weekly injections of NNC0487-0111 against placebo injections, both given under the skin. Participants also follow a reduced-calorie diet and increased physical activity as part of the study. Participants receive subcutaneous injections once a week of either NNC0487-0111 or a placebo. The study uses a randomized, parallel design with quadruple masking to assign treatments by chance. Treatments are given alongside lifestyle changes involving diet and exercise. During the trial, participants will be monitored over 92 weeks with regular assessments including body weight, waist circumference, blood pressure, blood sugar markers, cholesterol levels, and quality of life questionnaires. Safety is evaluated by tracking any adverse events. The primary measurement is the relative change in body weight from week 40 to week 92. The study is sponsored by Novo Nordisk AS and runs until mid-2028.