Columbus

Researchers are evaluating the safety and tolerability of AMG 691 in both healthy adults and adults with mild-to-moderate asthma. This Phase 1 study aims to assess how participants respond to single and multiple doses of AMG 691 compared to a placebo. The study includes adults aged 18 to 70 years and focuses on understanding the drug's effects in these populations. Participants receive either AMG 691 or a placebo through subcutaneous injections. The study includes single ascending dose and multiple ascending dose periods to carefully monitor reactions to different dosing levels. Healthy participants receive single or multiple doses, while participants with asthma receive multiple doses. Female participants must be of non-childbearing potential or use effective contraception if of childbearing potential. During the study, participants undergo medical evaluations, lung function tests, blood tests, and monitoring for any treatment-emergent adverse events over approximately 11 months. Researchers track lung function measures such as forced expiratory volume and biomarkers like blood eosinophils and exhaled nitric oxide. Safety and tolerability are closely monitored through regular assessments and questionnaires to evaluate asthma control and overall health.

Researchers are investigating the effects of multiple doses of vosoritide and comparing its therapeutic dose to human growth hormone (hGH) in children with idiopathic short stature (ISS). This Phase 2 study aims to understand how these treatments influence growth in this population. After an initial observation period of at least 6 months to measure baseline growth, participants are randomly assigned to receive either vosoritide, placebo, or hGH (the latter only in the United States). Those in the vosoritide and placebo groups undergo up to 6 months of randomized treatment, followed by open-label vosoritide until they reach near-final adult height or at least age 16 for females or 18 for males. Participants assigned to hGH receive open-label treatment for a minimum of 4 years. Throughout the study, safety is carefully monitored with clinical and imaging assessments focused on hips and lower extremities, as well as watching for hypotension, fractures, and slipped capital femoral epiphysis. An independent Data Monitoring Committee reviews safety data regularly. Study visits include a treatment completion visit about 4 weeks after the last dose, and follow-up assessments may continue annually through the end of the study. Key outcome measures include changes in annualized growth velocity at 6 months and changes in height and height Z-score after 4 years.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Researchers are evaluating the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty compared to autogenous bone graft in patients undergoing hindfoot or ankle fusion surgeries. This phase IV post-marketing study focuses on treating hindfoot and ankle disorders using these synthetic bone graft extenders or autograft material, both combined with rigid hardware fixation. The study aims to assess how well these treatments support bone fusion in various fusion procedures including ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or combinations of these. Approximately 126 adult patients aged 18 to 75 will be randomly assigned to receive either MagnetOs Putty/Easypack Putty or autograft from the calcaneus, distal tibia, or proximal tibia during their fusion surgery. The volume used depends on the fusion site, with 1-5 cc for smaller joints and up to 10 cc for the tibiotalar joint. The surgical procedures use rigid fixation with screws, plates, staples, nails, or combinations thereof. Treatments will be applied according to approved instructions for use. Following surgery, patients will be monitored over a year with scheduled visits at discharge and weeks 2, 6, 12, 24, and 52. Throughout the study, patients will undergo radiographic imaging at screening and weeks 6, 12, 24, and 52, with CT scans at weeks 24 and 52 to assess bone fusion. Weight-bearing X-rays will begin at week 12. Researchers will track the primary outcome of radiographic fusion via CT scan at 24 weeks post-operation. Additional follow-up will monitor safety and effectiveness for one year. If patients require secondary surgical intervention after 6 months, further CT scans may be omitted. The study collects detailed imaging, clinical evaluations, and safety data during this period.

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.

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.

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.

Researchers are evaluating the safety and tolerability of increasing doses of GSK3862995B. This study involves healthy participants receiving a single dose and participants with Chronic Obstructive Pulmonary Disease (COPD) receiving repeated doses to assess the drug's effects. The trial is a Phase 1, randomized, double-blind, placebo-controlled study designed to also investigate immunogenicity, pharmacokinetics, and pharmacodynamics of GSK3862995B. Participants are divided into two parts: Part A includes healthy volunteers aged 18 to 65 years who receive single ascending doses of GSK3862995B or placebo. Part B includes participants with COPD aged 40 to 75 years who receive repeated doses of the study drug or placebo. Dosing schedules and exact administration details are monitored closely throughout the study. During the study, participants undergo medical evaluations including laboratory tests, vital sign monitoring, cardiac assessments with 12-lead ECG, and recording of adverse events for up to 36 weeks in Part A and 48 weeks in Part B. Researchers will track changes in laboratory values, vital signs, and ECG parameters, as well as collect information on any adverse or serious adverse events. The study includes thorough safety monitoring to understand the tolerability of GSK3862995B over the study period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating additional dosing options of dulaglutide in children and adolescents aged 10 to less than 18 years with Type 2 Diabetes. This phase 3, open-label, multicenter study aims to assess the safety, tolerability, how the drug moves through the body, and effectiveness of dulaglutide at doses of 3.0 mg and 4.5 mg in this pediatric population. Participants have Type 2 Diabetes managed with diet, exercise, metformin, and/or basal insulin. Participants will receive dulaglutide administered subcutaneously at either 3.0 mg or 4.5 mg doses. The study is a single-arm design without a placebo or comparative drug group. The treatment period and follow-up last about 8 months. The study monitors participants throughout this time to evaluate the effects and safety of the dosing options. During the study, researchers will regularly assess participants for any serious adverse events related to the study drug from baseline through week 26. Participants will be monitored for safety, tolerability, and drug levels in the body. The main outcome measure is the number of participants experiencing one or more serious adverse events related to dulaglutide. Overall participation in the study lasts approximately 8 months, including screening and treatment.