Gardena

Researchers are studying an investigational drug called ALN-HSD in adults with Metabolic Dysfunction-Associated SteatoHepatitis MASH, a liver condition caused by fat buildup that damages liver cells and causes inflammation and scarring. This condition can worsen to cirrhosis and liver failure. The study aims to evaluate how ALN-HSD affects liver scarring related to MASH and to understand its impact on liver function and inflammation, as well as potential side effects and how the drug is processed in the body. Participants will be randomly assigned to receive either ALN-HSD or a placebo in a double-blind setup. The study involves a 52-week treatment period during which the effects of ALN-HSD on liver fibrosis and other liver-related biomarkers will be assessed. The trial includes genetic risk factor screening for enrollment and collects data on drug levels and metabolites. Treatment is administered according to the study protocol, with monitoring continuing through week 84 for adverse events. Throughout the study, participants will undergo liver biopsies and various laboratory tests to measure liver fibrosis, enzyme levels, and other biomarkers related to MASH. Researchers will track changes from baseline to week 52 in liver fibrosis and inflammation, along with monitoring adverse events until week 84. Participants are involved in regular assessments to evaluate the study drugs impact on their liver health over the course of the trial.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy and safety of AZD2373 in adults aged 18 to 70 years with APOL1-Mediated Kidney Disease AMKD who have high-risk APOL1 genotypes G1 and G2. The study aims to determine if AZD2373 reduces urine albumin-to-creatinine ratio UACR more than a placebo by Week 30. This Phase 2b trial involves participants with elevated UACR and adequate kidney function, excluding those on dialysis or with other organ transplants. The study consists of two parts. Part A randomizes participants equally to receive weekly subcutaneous injections of either 50 mg AZD2373, 150 mg AZD2373, or placebo. Part B randomizes participants in a 41 ratio to receive every-other-week injections of 150 mg AZD2373 or placebo, starting after Part A enrollment completes. Participants remain on treatment for a minimum of 30 weeks. After this period, they may enter an open-label extension study. Participants will have regular assessments throughout the study, including urine and blood tests to measure UACR, urine protein-to-creatinine ratio, kidney function eGFR, drug levels, and antibody development. Safety monitoring includes tracking adverse events during treatment and for 12 weeks afterward. These evaluations help assess how the study drug affects kidney disease markers and participant health over the treatment period.

Researchers are studying the long-term effects of aleniglipron, taken once daily, in adults with obesity or overweight who also have weight-related health problems. This Phase 3 global, randomized, placebo-controlled, and double-blind trial aims to evaluate how well aleniglipron works, how safe it is, and how well patients tolerate it over at least 76 weeks. The study also compares aleniglipron with placebo in terms of body weight changes, blood pressure, lipid levels, and patient-reported outcomes. Participants will be randomly assigned to receive one of three doses of aleniglipron or a placebo, all taken orally once daily. Along with the medication, all participants will follow a reduced-calorie diet and increase physical activity. The treatment phase lasts at least 76 weeks, during which effects on weight and other health measures will be assessed. During the study, participants will undergo assessments of body weight, waist size, blood pressure, cholesterol, blood sugar, and quality of life measures from the start through week 76. Researchers will monitor safety and tolerability throughout the treatment period. This long-term study will help understand the impact of aleniglipron on weight management and related health factors over more than a year of treatment.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.

Researchers are evaluating the effects of DONQ52 on small intestinal damage and celiac-related symptoms caused by gluten exposure in people with celiac disease who are trying to maintain a gluten-free diet. This Phase II study aims to compare the investigational drug DONQ52 to a placebo in participants with ongoing duodenal damage and persistent symptoms despite adhering to a gluten-free diet. The study focuses on patients with active celiac disease confirmed by specific genetic markers and clinical history. Participants are randomly assigned to receive either DONQ52 or a placebo, both given as subcutaneous injections according to protocol, along with oral Simulated Inadvertent Gluten Exposure SIGE capsules to mimic accidental gluten intake. The study period includes treatment and observation phases, with participants maintaining their gluten-free diet throughout. The treatment is administered over several weeks, and participants undergo two upper gastrointestinal endoscopies with duodenal biopsies to assess intestinal damage. During the study, participants will have regular evaluations including symptom diaries focusing on gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, and bloating. Laboratory tests will monitor drug levels, immune response, and safety. The main outcome measured is the change in the villous height to crypt depth ratio in the intestines over 27 weeks. Safety and side effects will be tracked up to 47 weeks. Participants will also be monitored for antibodies against DONQ52 and overall symptom changes over the course of the study.