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Found 28 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating how well two new study drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. This trial includes participants aged 8 to less than 18 years who have overweight or obesity. The study is designed in two parts: a main study and an extension study. The main study compares CagriSema, cagrilintide, semaglutide (an already approved drug), and placebo, with treatments assigned randomly. Participants receiving semaglutide will not continue to the extension study. The total time in the main study is about 1 year and 6 months, while those in the extension study may participate for up to about 4 years and 10 months. Participants in the main study will receive one of the four treatments by subcutaneous injection. In the extension study, participants will receive either CagriSema or cagrilintide. The study drugs are monitored closely for safety, and participants may experience side effects. The study compares these new treatments to a placebo and an existing approved drug to better understand their effects on weight management in young people. During the study, researchers will measure changes in body mass index (BMI) from baseline to week 68 as the primary outcome. Participants will undergo various assessments including laboratory tests and physical evaluations. The study tracks adherence to treatment and monitors safety throughout the study period. This comprehensive approach aims to provide detailed information about the efficacy and safety of these medications for managing weight in children and adolescents.
Actively Recruiting
Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.
Actively Recruiting
Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.
Actively Recruiting
Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.
Actively Recruiting
Researchers are evaluating the effect of the study drug ZT-01 on low blood sugar events during the night in adults with type 1 diabetes who frequently experience nighttime hypoglycemia. ZT-01 works by increasing glucagon, a hormone that helps raise blood sugar, and the study aims to find out if ZT-01 reduces the number of these low blood sugar episodes and how it affects overall blood sugar levels. The safety of ZT-01 will also be monitored throughout the trial. Participants will self-inject either ZT-01 or a placebo before bedtime during two separate 4-week treatment periods. They will receive one of three doses of ZT-01 (7 mg, 15 mg, or 22 mg) during one period and placebo during the other, with neither participants nor study staff knowing which treatment is given when. Participants will wear a study-provided continuous glucose monitor (CGM) during both periods to track blood sugar levels, and those not using their own CGM or unwilling to share their CGM data will wear the study CGM for an extra 4 weeks before treatment begins. Throughout the study, participants will attend six visits and two phone calls over about 16 weeks. They will provide blood and urine samples, have their blood pressure and temperature checked, and receive ECG tests at four visits. Some participants may join a sub-study measuring blood levels of ZT-01 and glucagon, requiring overnight stays at the study site. Participants will also complete daily diaries and upload CGM data to a study phone each day. The main outcome measured is the number of nighttime low blood sugar events during each treatment period.
Actively Recruiting
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.
Actively Recruiting
Researchers are evaluating the effects of different doses of SAR442970 compared to placebo in adults with moderate to severe Crohn's disease. This phase 2b, randomized, double-blind study aims to assess the safety and effectiveness of SAR442970 in treating this condition. Participants must have had Crohn's disease for at least three months and have shown inadequate response or intolerance to previous standard or advanced therapies. Participants will receive either SAR442970 or placebo through subcutaneous injections during the treatment period, which lasts up to 158 weeks. Eligible participants may continue into an open-label long-term extension phase for up to 104 weeks. The study includes three treatment groups to compare different doses of SAR442970 with placebo. Throughout the study, participants will be closely monitored with various assessments to measure their response to treatment, including the percentage achieving endoscopic response by Week 16. Researchers will also monitor safety and collect data over a total duration of up to 168 weeks. Participants will have regular visits for evaluations, including clinical assessments and adherence to treatment protocols.
Actively Recruiting
This research aims to evaluate the effectiveness of different doses of SAR442970 compared to placebo in adults with moderate to severe Ulcerative Colitis. It is a phase 2b, randomized, double-blind study conducted across multiple centers and countries. The study includes participants who have had active Ulcerative Colitis for at least three months and meet specific disease activity criteria measured by the modified Mayo Score. Participants will receive either SAR442970 or placebo through subcutaneous injections. The treatment period can last up to 158 weeks and includes a long-term open-label extension lasting up to 104 weeks for those who qualify. This design allows for assessment of both short-term and longer-term effects of the study drug. Throughout the study, researchers will monitor participants regularly to assess clinical remission using the modified Mayo Score at Week 16 as the primary outcome. Participants will undergo clinical evaluations, endoscopy, and other assessments to track disease activity and safety. The total study duration can extend up to 168 weeks, ensuring thorough long-term observation and safety monitoring.
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