Bihorel

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 safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism PA. This Phase III, global study involves approximately 250 participants and aims to reduce seated blood pressure and normalize the Renin Angiotensin Aldosterone System RAAS. Participants may have prior treatment with Mineralocorticoid Receptor Antagonists MRAs or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat or a matching placebo, both given orally once daily. The dose may be increased after two weeks depending on the participants clinical response and how well they tolerate the medication. The study is conducted across about 90 centers in 12 countries and involves parallel groups. Throughout the study, participants will have their seated systolic blood pressure and RAAS activity measured at week 8 to assess changes from baseline. Additional assessments include monitoring potassium levels, urine aldosterone, and albumin levels up to week 52. Safety and treatment effects will be regularly evaluated during visits. Total participation spans from screening through treatment and follow-up visits as scheduled.

Researchers are studying the use of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the Dexcom G6 Continuous Glucose Monitoring sensor in people with type 1 diabetes T1D in France. This observational study aims to evaluate the systems impact on blood sugar control under real-life conditions over one year. It also explores participant experiences related to quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality while tracking any complications related to the system. Participants include both adults and minors starting use of the system as part of their usual diabetes care. The study follows them for 12 months, collecting data on blood sugar control and system usage. There is no experimental treatment given instead, the study observes how the system performs when used in daily life by about 125 participants across multiple centers in France. Throughout the study, participants will complete self-reported questionnaires on quality of life and treatment experience at baseline, 3 months, and 12 months. Blood sugar data is gathered continuously from the glucose monitoring sensor to assess changes in time spent in target ranges and other glucose metrics. Safety is monitored by recording any adverse events related to the system. The study aims to understand how the system affects diabetes management and patient well-being over one year of use.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are studying volrustomig combined with other anticancer drugs to assess its safety, tolerability, how the body processes it, immune response, and ability to fight solid tumors, focusing on various types of metastatic non-small cell lung cancer mNSCLC. This Phase II open-label study includes two substudies, with participants randomized into different treatment arms based on tumor types and treatment regimens. Participants will receive volrustomig by intravenous infusion combined with chemotherapy drugs such as carboplatin, pemetrexed, ramucirumab, or paclitaxel, depending on the assigned treatment arm. The study tests different volrustomig dosing regimens alongside these anticancer agents to explore their combined effects in mNSCLC. Two substudies focus on non-squamous and squamousnon-squamous mNSCLC with specific treatment combinations. During the trial, participants will undergo regular monitoring for adverse events and treatment responses for up to nearly three years. Researchers will evaluate tumor response rates, disease control, survival, and drug levels in the blood. Safety and immune responses will also be tracked throughout. Participants can expect scheduled visits for infusions, assessments, and tests to measure the study treatments effects and safety over the study period.