Mont Royal

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.

Researchers are evaluating how the body responds to empasiprubart when given using an autoinjector AI. This study focuses on understanding the effects, how empasiprubart works in the body, and its safety. The study involves healthy adult volunteers aged 18 to 65 and is sponsored by argenx. The study has two parts, A and B. In part A, participants are randomly assigned to receive empasiprubart as a subcutaneous injection via autoinjector in the abdomen, via autoinjector in the thigh, or as an intravenous infusion. In part B, participants are randomized to receive empasiprubart either by subcutaneous autoinjector in the abdomen or by intravenous infusion. The treatment periods last up to 37 weeks for part A and up to 43 weeks for part B. During the study, participants will undergo various assessments to monitor drug levels, body response, and safety. Researchers will measure how empasiprubart is absorbed and processed in the body, including specific outcomes such as drug concentration over time and immune responses. Safety will be monitored by tracking any adverse events. Participants will attend regular visits for evaluations throughout the study period.

Researchers are evaluating ALN-2232, alone and combined with tirzepatide, in adults with obesity. The study aims to understand the safety, tolerability, effectiveness, and how the body processes these drugs. It includes participants with a body mass index between 30 and 40 kgm and low blood sugar levels, focusing on adults aged 18 to 65 years. Participants will receive either single or multiple doses of ALN-2232 or placebo, with some also receiving weekly doses of tirzepatide. ALN-2232 and placebo are given by injection under the skin. The study is divided into parts Part A involves single doses, while Parts B and C involve multiple doses, including combination with tirzepatide. During the study, participants will have regular visits for up to 12 months to assess safety by tracking adverse events and changes in body weight. Blood and urine samples will be collected to study drug levels and effects on body fat and lean mass. The research team will monitor participants closely throughout to understand the drugs impact on obesity over time.

Researchers are conducting a Phase 1, randomized, double-blind, placebo-controlled study to assess ALN-6222s safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in adults with obesity. This first-in-human trial focuses on participants with a body mass index between 30 and less than 40 kgm and aims to monitor adverse events and biological markers over time. Participants will receive a single subcutaneous dose of either ALN-6222 or a placebo. The study uses a parallel design with random allocation and triple masking to compare these two groups. The treatment period includes a single dose administration followed by monitoring and assessments extending up to 12 months postdose. During the study, participants will undergo evaluations including blood tests to measure drug concentrations and changes in protein markers. Safety is closely monitored by tracking adverse events for up to 12 months. The total participation duration includes dosing and long-term follow-up to evaluate the drugs effects and tolerability in adults with obesity.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.