Norwood

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

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 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 effects of ribupatide KAI-9531 given as a weekly subcutaneous injection compared to a placebo. It focuses on adults living with obesity or overweight who also have weight-related health issues but do not have diabetes. The study aims to understand how ribupatide influences body weight changes over time. Participants are randomly assigned to one of several groups receiving different doses of ribupatide once weekly or a matching placebo injection once weekly. The study is double-blind, so neither participants nor researchers know who receives the drug or placebo. Dosages range from Dose 1 to Dose 4, and the treatment period lasts up to 76 weeks. During the study, participants will have their body weight and various health indicators measured, including waist circumference, blood pressure, cholesterol levels, blood glucose, and quality of life related to weight. Safety is monitored by tracking adverse events and immune responses to the drug. The trial spans over approximately 76 weeks, with assessments at baseline and week 76 to evaluate changes and effects.

Researchers are evaluating the long-term effects of maridebart cafraglutide in adults with obesity or overweight. This extension study follows participants from a previous trial to assess the medications ongoing efficacy, safety, and tolerability over an extended period. The trial is designed as a phase 3 randomized and double-blind study to provide comprehensive information on treatment outcomes. Participants will receive different doses of maridebart cafraglutide administered by subcutaneous injection at varying intervals, including once every 4, 8, or 12 weeks. Some participants who received placebo or lower doses in the previous trial will undergo dose escalation or re-randomization to different dose groups or placebo. The study includes a dose-escalation phase for certain participants before initiating the assigned high dose. During the study, participants will be regularly monitored for changes in body weight compared to the original trial baseline, treatment-emergent adverse events, and serious adverse events. Additional assessments will track waist circumference, quality of life related to weight, and maintenance of weight loss. Participants are expected to complete visits and evaluations over approximately 48 weeks, with safety data collected up to 60 weeks from the start of the extension trial.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

Researchers are evaluating the drug Efsubaglutide Alfa in adults aged 18 to 75 who are overweight or obese. This phase 2, multicenter, double-blind, randomized, placebo-controlled study aims to assess the drugs effectiveness, safety, how the body processes it, and immune response in people with a body mass index BMI between 27 and 30 with at least one related health condition or a BMI of 30 or above with or without other health issues. The study includes a 2-week screening period, a 22-week treatment phase, and a 4-week follow-up after treatment ends. Participants will receive Efsubaglutide Alfa or a placebo through weekly injections. The drug dose starts at 1 mg and is increased every two weeks through a series of steps until reaching a target dose that varies by study group, ranging from 20 mg to 80 mg. Some groups receive the highest dose every one or two weeks, and the total treatment lasts for 22 weeks. The study compares multiple dosing schedules to evaluate effects across different doses and frequencies. During the trial, participants will attend scheduled visits for weight and body measurements, blood pressure, and blood tests including blood sugar and cholesterol levels. Body composition will be measured using DEXA scans. Safety will be monitored throughout by tracking side effects and mental health using questionnaires. Blood samples will also be collected to measure drug levels and immune response. Overall, the study helps understand how the drug affects body weight and other health markers in people with overweight or obesity over about 28 weeks from screening to follow-up.

Researchers are evaluating whether Ultra Low Frequency ULF neuromodulation can reduce chronic nociceptive low back pain in adults and assessing its safety compared to conventional medical management CMM. This prospective, multi-center, randomized controlled trial focuses on adults with chronic, intractable axial low back pain with prominent nociceptive features, aiming to understand if ULF therapy offers better pain relief and any unexpected medical issues over 24 months. Participants will be randomly assigned in a 21 ratio to either receive ULF therapy combined with CMM or CMM alone. Those in the ULF group will first undergo a temporary trial phase and may receive a permanent implant if they experience at least 50% pain relief. At six months, participants can choose to switch to the other treatment if eligible. The primary outcome, back pain relief measured by a visual analog scale VAS, will be evaluated at three months with continued follow-up for a total of 24 months. During the study, participants will attend regular clinic visits for checkups and data collection. Researchers will assess pain levels, functional improvement, disability, opioid use, and quality of life using various tools including VAS and the Oswestry Disability Index ODI. Safety and treatment effects will be monitored over the entire two-year period to provide comprehensive information about ULF neuromodulation compared to standard care.