Aguni

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

Researchers are evaluating the use of oral ivosidenib in adults with locally advanced or metastatic conventional chondrosarcoma that has an IDH1 gene mutation. This Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study focuses on participants who have not had curative surgery and have experienced disease progression or recurrence. Participants may have had up to one prior systemic treatment for their advanced or metastatic chondrosarcoma. The study aims to measure progression-free survival as the primary outcome, especially in Grades 1 and 2 patients, along with overall survival and other efficacy and safety outcomes. Participants will be randomly assigned to receive either ivosidenib 500 mg orally once daily as two 250 mg tablets or a matching placebo. Treatment will continue until disease progression confirmed by blinded independent central review, unacceptable side effects, pregnancy, death, withdrawal, loss to follow-up, or study end, with an expected average treatment duration of about two years. Those on placebo who experience disease progression and meet criteria may cross over to receive ivosidenib. Throughout the study, participants will undergo regular imaging assessments to monitor tumor response using RECIST v1.1 criteria. Various patient-reported outcomes, adverse event monitoring, and laboratory tests including plasma ivosidenib and 2-hydroxyglutarate levels will be collected. The study includes follow-up for up to 5 years to evaluate long-term survival, disease control, and safety. The total participation duration varies depending on individual progression and study timelines.