Columbus

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

This research aims to evaluate the effects of different doses of vosoritide and compare the therapeutic dose of vosoritide to human growth hormone hGH in children diagnosed with idiopathic short stature ISS. The study is a Phase 2, randomized, controlled trial that seeks to understand how these treatments influence growth in affected children. Participants will first undergo a minimum 6-month observation period to assess their baseline growth. Then, those assigned to the vosoritide and placebo groups will receive randomized treatment for at least 6 months, with placebo limited to a maximum of 6 months. After this, open-label vosoritide treatment will continue until participants reach near-final adult height or at least 16 years for females and 18 years for males, whichever is later. Participants randomized to the hGH group will receive open-label hGH treatment for a minimum of 4 years. Study treatments involve daily injections. Throughout the study, participants will attend regular visits for clinical and imaging assessments, including evaluations of hips and lower extremities. Researchers will monitor safety concerns such as hypotension, fractures, and slipped capital femoral epiphysis, with oversight from an independent Data Monitoring Committee. The main outcomes measured include changes in annualized growth velocity at 6 months and height changes over 4 years. Follow-up assessments will continue as needed, including safety monitoring, until study completion, which could last up to 15 years.

This research aims to assess the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, synthetic bone graft extenders, compared to autogenous bone graft in patients undergoing hindfoot or ankle fusions. The study focuses on treating hindfoot and ankle disorders requiring rigid hardware fixation and supplemental bone graft or substitute. It is a randomized, single-blind, controlled, multi-center phase IV post-marketing study involving adult patients aged 18 to 75 years. Participants will be randomly assigned to receive either MagnetOs PuttyEasypack Putty or autograft harvested from the calcaneus, distal tibia, or proximal tibia along with rigid hardware fixation during surgery. The volume used depends on the joint fused, with 1-5 cc for talonavicular, calcaneocuboid, and subtalar joints, and up to 10 cc for the tibiotalar joint. The surgical procedures include ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints. Participants will be followed up with radiographs at screening and weeks 6, 12, 24, and 52 post-surgery, with CT scans at weeks 24 and 52 to evaluate radiographic fusion. Functional assessments will also be conducted throughout the study period. If secondary surgical interventions occur after six months, CT scans may be adjusted. The primary outcome is radiographic fusion by CT scan at 24 weeks post-operation. Safety and efficacy are monitored for one year after surgery, with weight-bearing X-rays starting at week 12.

This research aims to evaluate how well two new drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. The study includes participants aged 8 to under 18 years who have overweight or obesity. It is a Phase 3 trial that compares these new drugs with semaglutide, a drug already prescribed for weight management, and a placebo to understand their effects on weight loss. Participants in the main study are randomly assigned to receive one of four treatments CagriSema, cagrilintide, semaglutide, or placebo. All treatments are given once weekly as subcutaneous injections, starting with a dose escalation phase lasting up to 16 weeks, followed by a maintenance phase for 52 weeks. Those who receive semaglutide do not join the extension study. Participants in the extension study continue treatment with either CagriSema or cagrilintide for up to 156 weeks, while placebo participants follow a specific dosing regimen before continuing in the extension. During the study, participants will be monitored for changes in body mass index BMI and weight over time, with assessments at baseline, week 68, and for some measures, week 224. Researchers will also track body composition, metabolic markers, quality of life, and safety events. The entire duration for participants can be up to nearly five years if they take part in both the main and extension studies, involving regular visits and evaluations to understand the treatments effects and safety.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are studying dulaglutide, a medication given by injection under the skin, to explore new dosing options for children and teenagers aged 10 to under 18 years with Type 2 Diabetes. This phase 3 trial focuses on evaluating the safety of dulaglutide doses 3.0 mg and 4.5 mg in pediatric participants who have Type 2 Diabetes managed with diet, exercise, and stable doses of metformin andor basal insulin. The study is sponsored by Eli Lilly and Company and aims to better understand how dulaglutide works in this younger population. Participants will receive dulaglutide subcutaneously, with no placebo group as this is a single-group study. The study treatment will be administered over a period of about eight months. Throughout the study, researchers will closely monitor the number of serious side effects that might be related to the drug. Additional evaluations will include measuring dulaglutide levels in the blood over time, changes in blood sugar control Hemoglobin A1c, body weight, cholesterol levels, quality of life assessments, and beta cell function. During the study, participants will attend visits where blood samples and other health assessments will be performed at specific times including baseline, week 26, and week 30. Researchers will use these assessments to track the medications impact and monitor for safety. Participation involves regular monitoring over approximately eight months, allowing researchers to collect important data on how dulaglutide affects young people living with Type 2 Diabetes.