Needham

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on body weight reduction in adults with obesity or overweight who do not have type 2 diabetes. This Phase 2b clinical trial aims to study the weight-lowering effectiveness and safety of these drugs compared with placebo under a randomized, double-blind, placebo-controlled design. Participants are assigned to one of several groups receiving macupatide, eloralintide, both drugs together, or placebo, all administered by subcutaneous injection. The study lasts about 64 weeks, including treatment and follow-up periods, with dosing at different levels and combinations to assess the interventions effects on weight management. During the study, participants undergo regular visits for assessments including body weight measurements up to at least week 36 and beyond. Researchers monitor changes in body weight, body mass index BMI, and the proportion of participants who achieve significant weight loss percentages. Safety and adherence are also tracked throughout the trial to evaluate the treatments over the full participation period.

This trial studies males aged 5 to 55 years with genetically confirmed Barth Syndrome BTHS, a rare condition affecting muscles and heart function. It is a Phase 3b4 randomized, double-blind, placebo-controlled clinical trial designed to confirm the effectiveness and safety of elamipretide, a drug approved in the US under the name FORZINITY11, for improving muscle strength in both adults and children with BTHS weighing at least 30 kg. The study aims to verify its impact on knee extensor muscle strength, an important clinical measure. Participants will receive either a daily subcutaneous injection of elamipretide or a matching placebo for 72 weeks. The study compares these two groups to evaluate the drugs pharmacokinetics, safety, and efficacy over this period. Elamipretide is administered via sterile multi-dose vials, and the trial follows a parallel design with random assignment to treatment arms. During the trial, participants undergo various assessments including echocardiograms to measure heart function, functional tests, and evaluations of muscle strength. Researchers will monitor safety, drug effects, and adherence throughout the 72-week treatment. The main outcome is effectiveness at 72 weeks, with additional secondary endpoints also evaluated. The study is sponsored by Stealth BioTherapeutics Inc. and continues to monitor participants until late 2029.

Researchers are studying the long-term effects of aleniglipron, taken once daily, in adults with obesity or overweight who also have weight-related health problems. This Phase 3 global, randomized, placebo-controlled, and double-blind trial aims to evaluate how well aleniglipron works, how safe it is, and how well patients tolerate it over at least 76 weeks. The study also compares aleniglipron with placebo in terms of body weight changes, blood pressure, lipid levels, and patient-reported outcomes. Participants will be randomly assigned to receive one of three doses of aleniglipron or a placebo, all taken orally once daily. Along with the medication, all participants will follow a reduced-calorie diet and increase physical activity. The treatment phase lasts at least 76 weeks, during which effects on weight and other health measures will be assessed. During the study, participants will undergo assessments of body weight, waist size, blood pressure, cholesterol, blood sugar, and quality of life measures from the start through week 76. Researchers will monitor safety and tolerability throughout the treatment period. This long-term study will help understand the impact of aleniglipron on weight management and related health factors over more than a year of treatment.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are building on previous studies involving over 2,000 people to improve machine learning models that predict how individuals respond to different foods. The goal is to advance precision nutrition science and provide personalized dietary advice. This study uses both controlled dietary tests and free-living periods to observe responses to various meals and factors like exercise, sleep, and time of day. It also incorporates a commercial product to reach many participants who collect data through digital and biochemical devices. Participants will take part for 6 to 14 days. On the first day, they will wear a continuous glucose monitor on their arm. They will then eat two standardized meals each day, provided by the study team, and track their food intake using a digital app. After this period, participants can eat freely but must continue logging all meals, snacks, drinks, sleep, physical activity, mood, hunger, and medication use on the app. The study includes use of wearable devices and collection of blood and stool samples among users of the commercial product. Participants will complete questionnaires about their diet, lifestyle, and psychological state before and during the study. Continuous glucose levels will be monitored every 5 minutes during the intervention. Regular contact via phone, app, and messages will support compliance. Some participants may join a follow-up study to try dietary advice from the app for up to a year, reporting weight, bowel habits, hunger, energy, and app usage. The study measures glucose, gut microbiome diversity, blood lipids, hunger, and other health indicators throughout the study period.

Researchers are conducting a cluster randomized clinical trial to evaluate a multi-level intervention involving shared decision making training for breast surgeons and a patient decision aid for women aged 70 and older with low-risk Stage I breast cancer. This study aims to improve treatment decisions and outcomes by supporting communication between surgeons and older women facing breast cancer treatment choices. The trial is being conducted across seven large health systems in the U.S. The intervention includes a one-hour shared decision making training for surgeons and providing eligible patients with a tailored decision aid before their first surgical visit. Surgeons randomized to the intervention arm receive training via live televideo or video recording and ongoing support including access to decision tools and feedback on challenging cases. Patients receive the decision aid by mail, email, or patient portal. Surgeons in the usual care arm continue their standard treatment discussions without additional support. The study plans to recruit 44 surgeons and over 1,100 women over three years. Participants will be observed through medical record reviews to determine treatments received and outcomes such as breast cancer recurrence and survival over 6 months to 3.5 years. Patients and caregivers will complete surveys at one week and six months after the initial surgical visit to report on shared decision making quality, knowledge, decisional conflict, quality of life, and treatment satisfaction. Surgeons will complete baseline and end-of-study surveys, with some participating in interviews to provide feedback. The study will also assess healthcare costs and the feasibility of implementing the intervention in clinical practice.

This research aims to evaluate how the prosthetic replacement of the ocular surface ecosystem PROSE treatment may affect mental health, focusing on mood disorders like depression. It explores the connection between changes in mental health and improvements in eye symptoms or vision. PROSE is used for certain eye surface diseases, including dry eye and ocular Graft versus Host Disease, which are linked to mental health challenges due to pain and vision loss risks. PROSE treatment involves customizing a rigid gas permeable scleral lens that protects and lubricates the eye by filling it daily with preservative-free saline. This treatment is designed to reduce eye pain, prevent damage, and improve vision. The study follows patients considering PROSE or scleral lenses for their eye conditions, assessing their mental health and eye symptoms over time. Participants will be assessed using questionnaires measuring depression PHQ-9, eye symptom severity Ocular Surface Disease Index, and quality of life Visual Function Questionnaire 25 at enrollment and at 28 and 84 days after receiving PROSE treatment. The study collects data to understand how eye treatment might relate to changes in mood and daily functioning over six months.