Danville

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are investigating how well retatrutide works and how safe it is for relieving chronic low back pain in adults who are overweight or have obesity. This Phase 3 study focuses on people with this specific type of ongoing back pain and a body mass index (BMI) of 27 or higher. Participants will be followed for about 80 weeks to assess treatment effects. Participants will receive either retatrutide or a placebo, both given by subcutaneous injection once a week. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. This design helps compare the effects of retatrutide against no active treatment over the study period. During the study, researchers will monitor changes in pain intensity using a numeric rating scale and track body weight changes from the start of the study up to 72 weeks. Participants will undergo regular assessments to evaluate safety and treatment impact. The entire participation will last around 80 weeks, allowing careful observation of long-term effects and safety.

Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter compared to a standard non-coated PTA balloon catheter. This trial focuses on treating blockages in the infrapopliteal arteries—arteries below the knee and above the ankle—in patients with chronic limb-threatening ischemia (CLTI) classified as Rutherford category 4 or 5. The study aims to determine if the coated balloon provides better results and similar safety outcomes to the standard device. Participants will undergo treatment with either the AcoArt Litos coated balloon or the standard PTA balloon catheter. The study restricts treatment to blockages located between the P3 segment of the popliteal artery and the tibiotalar joint and requires successful pre-dilatation of the target lesion. The procedure will be performed following specific angiographic criteria, including vessel diameter and lesion length. Patients will not have prior surgeries or interventions within 2 weeks before or planned 30 days after treatment. During the study, participants will be closely monitored with follow-up evaluations to assess limb preservation and vessel openness at 12 months, as well as safety outcomes such as major adverse limb events and peri-operative death within 30 days. The study requires commitment to follow-up visits and adherence to study protocols, with measurements including angiographic assessments and clinical evaluations to determine the treatment’s impact over time.

Researchers are evaluating the effects of KAI-9531, a weekly subcutaneous injection, on body weight changes in adults living with obesity or overweight who also have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare KAI-9531 against a placebo to understand its impact on weight reduction over time. Participants will receive either KAI-9531 or a placebo as a subcutaneous injection once a week. The study focuses on the percent change in body weight from the start of treatment to week 76. Both the treatment and placebo groups will be monitored throughout the trial to assess efficacy and safety. During the study, participants will have their body weight measured at baseline and week 76 to track changes. Researchers will also monitor safety and other health factors throughout the trial. The total participation duration includes the treatment period up to week 76, with assessments to evaluate the impact of the injections on weight and related health conditions.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.

Researchers are evaluating the effectiveness and safety of ZILRETTA, a medication given as a single injection into the shoulder joint, in adults aged 50 to 80 years with glenohumeral osteoarthritis (OA). This Phase 3, multi-center, randomized, double-blind study compares ZILRETTA to a placebo (normal saline) to see its impact on shoulder pain. The study aims to measure pain relief at 12 weeks and assess safety over 24 weeks. Participants will receive one injection of either 32 mg ZILRETTA or placebo into the affected shoulder joint. After the injection, they will be followed for 24 weeks, with eight outpatient visits scheduled at 2, 4, 8, 12, 16, 20, and 24 weeks. The study includes a screening period lasting from 10 to 35 days before treatment. During the study, participants will complete pain and sleep interference questionnaires daily using an electronic diary. Throughout the study, participants will undergo physical exams, shoulder assessments, and X-rays. Blood samples will be taken to monitor safety, and vital signs will be checked regularly. Researchers will collect information on any side effects, use of other medications, and rescue pain medicine. The main outcome is the change in worst daily pain score at 12 weeks, with ongoing safety monitoring through the 24-week study period.