Gardena

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic dysfunction-Associated SteatoHepatitis (MASH), a type of liver disease where fat buildup causes liver cell damage, inflammation, and scarring. This condition can lead to serious complications like cirrhosis and liver failure. The study aims to assess how ALN-HSD affects liver scarring associated with MASH and to explore its impact on liver function, inflammation, side effects, and how the drug and its breakdown products appear in the blood. Participants will receive either ALN-HSD or a placebo according to the study protocol in this Phase 2, randomized, double-blind, placebo-controlled trial. The treatment is given based on the protocol's schedule, but specific dosing details are not provided. The study focuses on adults with specific genetic risk factors for MASH and with certain disease stages, ensuring a targeted precision medicine approach. During the study, participants will be monitored for changes in quantitative liver fibrosis from the start of the study to week 52. Researchers will evaluate liver scarring, liver function, inflammation, drug levels in the blood, and any side effects. The study includes genetic testing and specific liver assessments like FibroScan and FAST scores. Participants will be followed closely to understand the drug's effects and safety over the one-year period.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of AZD2373 in adults aged 18 to 65 diagnosed with APOL1-Mediated Kidney Disease (AMKD) who carry specific high-risk APOL1 genotypes (G1 and G2). This Phase 2b study aims to see if AZD2373 can reduce the urine albumin-creatinine ratio (UACR) more than a placebo by the 30th week of treatment. Participants must have significant kidney involvement as indicated by UACR and estimated glomerular filtration rate (eGFR) levels. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple treatment groups. The study includes three treatment arms: two different doses of AZD2373 and a placebo, all delivered via accessorized pre-filled syringes as injections. Participants will be randomly assigned to one of these groups and neither they nor the study staff will know their assignment during the trial. Treatment will last for a minimum of 30 weeks, continuing until the last participant completes this period. The study also uses a specialized APOL1 genotyping test to confirm participants' eligibility based on their genetic profile. Participants will undergo screening with urine tests to confirm UACR levels and blood tests for kidney function before joining. During the study, researchers will monitor changes in UACR from baseline to week 30 to assess treatment effects. Safety and tolerability will also be closely observed throughout the treatment period. Around 96 participants will be enrolled, with about 32 in each group, and all will be followed until the last participant completes the 30 weeks of treatment.

Researchers are evaluating the effects of survodutide on adults living with obesity who have a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH), along with moderate or advanced liver fibrosis. The study focuses on whether survodutide can improve liver function and reduce liver damage in these participants. This Phase III trial aims to assess both the effectiveness and safety of survodutide over a long-term period. Participants are randomly assigned to one of two groups: one receiving weekly injections of survodutide and the other receiving placebo injections that look like the medicine but contain no active drug. The doses of survodutide are gradually increased until the target dose is reached. All participants receive counseling to support healthy diet changes and regular exercise throughout the study. The study lasts up to 7 years, with frequent visits to the study site or remote video calls. In the first year, visits occur every 2 weeks, then every 4 to 6 weeks, and later every 3 months alternating between in-person and remote. Throughout the study, researchers monitor participants' health, liver condition through imaging and biopsies, body weight, digestive system effects, and questionnaires about symptoms and quality of life. The main outcomes include liver fibrosis improvement, resolution of MASH without worsening fibrosis, and long-term safety and efficacy measures.

Researchers are studying women with nonatypical endometrial hyperplasia (NAEH), a condition where the lining of the uterus becomes too thick but is not cancerous. This condition is often caused by hormone imbalances and can cause abnormal vaginal bleeding or irregular periods. If untreated, NAEH may lead to cancer. Currently, no approved treatments exist for this condition, creating a need for new therapies. This Phase 3 study aims to evaluate whether Mirena, a progesterone-releasing intrauterine device, can help restore the uterine lining to normal and assess its safety compared to oral medroxyprogesterone acetate (MPA).

Researchers are evaluating the safety and effectiveness of a new endoscopic intestinal re-cellularization therapy called ReCET in people with type 2 diabetes who are not adequately controlled on non-insulin glucose-lowering medications. This multi-center, randomized, double-blind, sham-controlled study aims to compare the ReCET therapy with a sham procedure where the device is inserted but no treatment is applied. Participants will be followed for a total of 12 months, with the primary outcome measured by HbA1c levels 6 months after the procedure. After 12 months, those initially in the sham group may receive the ReCET therapy if they choose to cross over. The ReCET therapy involves using a catheter inserted through the mouth into the first part of the small intestine (duodenum) to deliver a non-thermal pulsed electric field that promotes cell regeneration. Participants will either receive this active treatment or a sham procedure involving only catheter placement without therapy. Both groups will be monitored closely for 12 months following their respective procedures. After one year, participants in the sham group have the option to receive the ReCET treatment. During the study, participants will undergo regular assessments including laboratory tests to monitor blood sugar control and safety. Researchers will track HbA1c levels, which indicate average blood glucose, at 6 months post-procedure to evaluate effectiveness. Participants must attend scheduled visits and comply with all study procedures, including safety monitoring, throughout the 12-month follow-up period. This careful monitoring helps ensure any changes in diabetes management or health status are recorded and evaluated.

Researchers are evaluating the effects of DONQ52 on improving small intestinal damage and reducing symptoms related to gluten exposure in adults with active celiac disease who are trying to maintain a gluten-free diet. This Phase II study compares DONQ52 treatment to placebo controls in participants who continue to have duodenal mucosal damage and symptoms despite following a gluten-free diet. Participants will receive subcutaneous injections of either DONQ52 or a placebo, along with oral capsules simulating inadvertent gluten exposure (SIGE). The study involves a randomized, double-blind, placebo-controlled design with multiple centers involved in the trial. During the study, participants will undergo two upper gastrointestinal endoscopies with duodenal biopsies to assess the villous height to crypt depth ratio, a measure of intestinal damage, from baseline to week 27. Researchers will monitor gluten-related symptoms and mucosal healing while ensuring adherence to the gluten-free diet and study procedures. Safety and efficacy will be evaluated throughout the trial period.