Lincoln

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are studying a trial medicine called MK-7262 to lower the level of Lipoproteina or Lpa in the blood. This trial also looks at another medicine named enlicitide, which lowers low-density lipoprotein cholesterol LDL-C. The study aims to find out if taking MK-7262 alone or together with enlicitide works better than a placebo in lowering Lpa and LDL-C levels. The safety and tolerability of these medicines are also being evaluated. Participants will be randomly assigned to one of four groups. One group will take both MK-7262 and enlicitide placebos, the second will take enlicitide with an MK-7262 placebo, the third will take MK-7262 with an enlicitide placebo, and the fourth will take both MK-7262 and enlicitide. All treatments are oral tablets taken once daily for about 12 weeks. During the study, participants will have their Lpa and LDL-C levels measured at baseline and at weeks 8 and 12 to assess changes. Researchers will monitor any adverse events and whether participants stop treatment due to side effects, with safety observed for up to approximately 20 weeks. The study also tracks other related outcomes like percentages of participants reaching specific Lpa levels. Overall participation lasts up to about 12 weeks of treatment plus follow-up.

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

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 conducting a multicenter, randomized, double-blind Phase 2 study to evaluate the pharmacodynamics, safety, and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484 alone, inclisiran alone, and placebo in adults with hypertension and hypercholesterolemia. The study focuses on understanding how these treatments affect certain blood markers and blood pressure in this population. Participants receive a single dose of either the combination of QCZ484 and inclisiran, QCZ484 alone, inclisiran alone, or placebo on Day 1. The study lasts up to 12 months and includes a screening period with two visits to confirm eligibility, followed by the treatment administration at the baselinerandomization visit. After treatment, participants enter a safety follow-up phase, with an option to join an open-label extension study instead of the follow-up. During the study, participants undergo various assessments including measurements of PCSK9 and AGT levels at baseline and Month 3, blood pressure and LDL cholesterol levels at baseline, Month 3, and Month 6, along with monitoring for treatment-emergent adverse events and changes in laboratory tests and vital signs for up to 12 months. These evaluations help researchers understand the effects and safety of the treatments over time.

This observational study focuses on adults with Type 2 Diabetes Mellitus T2DM who are evaluated to identify and describe their condition and treatment patterns. The study aims to better understand patients with T2DM, particularly those whose diabetes management is not fully controlled by lifestyle changes or stable glucose-lowering medications. AstraZeneca sponsors this study to help link patients to ongoing or future T2DM clinical trials. Participants with T2DM will undergo assessments including blood sample collection about 2 mL and evaluation of medical history, medication use, and HbA1c blood sugar levels. The study involves a single visit where these data are collected to characterize patient demographics and treatment trends. Those interested and willing to participate may be referred to other relevant T2DM studies based on these findings. During the single study visit, participants provide informed consent and undergo blood sampling and questionnaires about their health and medication use. Researchers measure HbA1c levels and document medical and surgical histories. The main outcomes include demographic information, medication usage patterns, and the potential referral of participants to future T2DM trials. The entire participation lasts only one day, focusing on capturing detailed baseline information.

Researchers are evaluating the effectiveness of oral KAI-7535 taken once daily compared to a placebo in adults living with obesity or overweight who have at least one weight-related health condition, excluding those with diabetes mellitus. The study also examines how well KAI-7535 works in participants with type 2 diabetes mellitus. Safety, tolerability, and other weight-related results will be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a placebo once a day. The study includes multiple dosing schedules of KAI-7535 to evaluate its effects. The trial follows a parallel design with a quadruple masking method to ensure unbiased results. The treatment period lasts up to 44 weeks. Throughout the study, participants will have their body weight and body mass index measured at the start and at week 44. Researchers will track the percentage change in body weight and the number of participants achieving weight loss of 5% or 10%. Safety and tolerability will also be monitored. The entire participation period can last over 44 weeks, including screening and follow-up assessments.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.