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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the drug brenipatide compared to a placebo in adults with Alcohol Use Disorder AUD and hazardous alcohol use. The study aims to assess the drugs effect on drinking patterns and its safety. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and will last about 56 weeks. Participants receive escalating doses of brenipatide or placebo, administered as subcutaneous injections. The study includes a multi-period design with two experimental periods for brenipatide dosing and a placebo group. Participants or trained support persons will perform self-injections, and the study medication is blinded to ensure unbiased results. Throughout the trial, participants will attend regular visits for assessments including drinking behavior using the Timeline Followback Method, alcohol craving scales, health questionnaires, and body weight measurements. Blood samples will be taken to analyze drug levels and immune response. Participants will keep diaries and complete questionnaires to monitor adherence and effects. Safety and tolerability will be closely monitored during the 56-week participation period.

Age: 18Years - 75YearsAll GendersPhase 3
119 locations
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Actively Recruiting

Researchers are evaluating the effect of abelacimab compared to a placebo on reducing the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients, including those who may have increased bleeding risks and cannot or choose not to take standard blood thinners. Participants will be randomly assigned to receive either abelacimab 150 mg or a matching placebo through a monthly subcutaneous injection. The study is designed as a double-blind, placebo-controlled trial to monitor the safety and efficacy of abelacimab over a period of up to 30 months. During the study, participants will be closely monitored for the time to first occurrence of ischemic stroke, systemic embolism, and bleeding events classified by the Bleeding Academic Research Consortium. Researchers will also track cardiovascular and all-cause mortality, as well as other cardiovascular events. Participants will undergo regular assessments, including electrocardiograms and clinical evaluations, throughout the trial to ensure safety and collect data on treatment effects.

Age: 65Years +All GendersPhase 3
734 locations