Lampasas

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the safety and effectiveness of UBT251, a medicine not yet available for prescription, in adults with type 2 diabetes. This study compares UBT251 with semaglutide, an already approved treatment, and their respective placebos. The goal is to see how well different doses of UBT251 lower blood sugar over time. Participants will be randomly assigned to receive either UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. All treatments are given once weekly by injection under the skin. The study follows participants over several weeks, measuring effects at weeks 16, 28, and 40, focusing on blood sugar control and body weight changes. Throughout the study, participants will have regular assessments including blood tests to measure glycated hemoglobin HbA1c, insulin resistance, beta-cell function, fasting glucose, body measurements, blood pressure, cholesterol levels, and other health markers. Safety is monitored by tracking any adverse events, with total participation lasting up to 40 weeks of treatment plus additional safety follow-up.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the effect of ION775 on fasting triglyceride levels in adults with hypertriglyceridemia and severe hypertriglyceridemia. This phase 2, open-label study aims to assess the safety, tolerability, and efficacy of ION775 in reducing triglyceride levels in these participants. The study is sponsored by Ionis Pharmaceuticals, Inc. Participants will be randomly assigned to one of three groups receiving ION775 by subcutaneous injection. The study includes a 4 to 6 week screening period, followed by a 6-month treatment period where participants receive ION775, and then a 6-month post-treatment follow-up period to monitor outcomes and safety. The study measures changes in fasting triglycerides and other cholesterol-related markers. During the study, participants will have assessments at baseline and at month 6 to measure triglyceride levels and other cholesterol components such as apolipoprotein C-III, very low-density lipoprotein cholesterol, remnant cholesterol, and non-high-density lipoprotein cholesterol. Safety is monitored through treatment-emergent adverse events and laboratory evaluations up to 12 months. Participants are involved in regular visits during the treatment and follow-up periods to evaluate the effects and safety of ION775.

Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.

Researchers are evaluating the drug clofutriben, an 11-hydroxysteroid dehydrogenase type 1 HSD-1 inhibitor, in adults with type 2 diabetes who have elevated cortisol levels. This Phase 2 trial aims to understand how different doses of clofutriben affect blood sugar control and to find suitable doses for further studies. The trial involves two parts an initial screening phase and a treatment phase, conducted in multiple centers with participants randomly assigned to groups. The first part, lasting about 5 to 9 weeks, includes screening tests such as the dexamethasone suppression test to identify eligible participants with elevated cortisol. In the second part, participants are randomly assigned to receive either placebo or one of four doses of clofutriben taken once daily by mouth for 24 weeks. After treatment, a follow-up phone call occurs 4 weeks later to check on participants. Participants will undergo various assessments including blood tests to measure cortisol levels and blood sugar control glycated hemoglobin A1c and fasting plasma glucose. The study monitors changes in these measures from baseline through the 24-week treatment period. The trial also tracks safety and treatment adherence. Total participation time includes screening, a 24-week treatment, and a follow-up period, extending to the trials completion date in mid-2028.