Ammon

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 efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

This research aims to evaluate how tirzepatide affects body weight and cardiovascular risk factors in adolescents aged 12 to 17 who have obesity along with multiple weight-related health conditions. The study is a Phase 3 clinical trial focusing on the safety and effectiveness of tirzepatide combined with healthy nutrition and physical activity. Participants will be randomly assigned to receive either tirzepatide or a placebo through weekly injections under the skin. The main study period lasts about 72 weeks with up to 23 visits, and participants who completed a prior related study and meet certain criteria may continue receiving tirzepatide for an additional 156 weeks while maintaining lifestyle interventions. During the study, participants will undergo various assessments including measurements of body mass index BMI, blood pressure, blood sugar HbA1c, triglycerides, body fat by DXA scan, and sleep apnea index. Researchers will monitor changes from baseline to week 72 in these areas to evaluate the treatments impact. Safety and adherence to the study schedule will also be closely observed throughout the trial.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are evaluating the effectiveness, safety, and drug levels of Deucravacitinib BMS-986165 in adolescents aged 12 to less than 18 years who have moderate to severe plaque psoriasis. This phase 3 study is randomized, double-blind, and placebo-controlled to thoroughly assess the treatments impact on this skin condition. The study is sponsored by Bristol-Myers Squibb and aims to provide detailed information on how Deucravacitinib works in this younger population. Participants will receive either Deucravacitinib or a placebo, with doses given on specified days as part of the treatment. The study groups include an active drug group and a placebo group, and the design is parallel to compare these treatments directly. The treatment period includes monitoring drug levels and observing the participants responses over time. During the study, participants will be regularly assessed for improvements in their psoriasis using measures such as the Psoriasis Area and Severity Index PASI and the static Physicians Global Assessment sPGA at week 16. Additional evaluations include body surface area involvement, itch severity, quality of life, and antibody protection. Safety is closely monitored through laboratory tests, physical exams, vital signs, and adverse event tracking for up to five years, with ongoing measurement of growth and sexual maturation during this time.

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.

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are investigating how well and safely Eloralintide LY3841136 works in adults who are overweight or obese and suffer from osteoarthritis pain in the knee. This study supports two independent phase 3 trials under a master protocol, focusing on improving knee osteoarthritis symptoms and body weight management in this population. Participants will receive either Eloralintide or a placebo by subcutaneous injection once weekly. The study follows a randomized, double-blind, parallel design with two separate arms for each independent study. Treatment and observation will last approximately 75 weeks, including the screening period. During the study, participants will undergo various assessments including measurements of body weight, knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, blood pressure, physical function, inflammation markers, and metabolic parameters. Researchers will also track medication use, walk test performance, and other health-related quality of life measures over time to evaluate the effects and safety of Eloralintide.

This research aims to evaluate the safety and immune response of a new pneumococcal vaccine called PG4 in children and adolescents aged 15 months to 18 years. It compares this new vaccine to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC, focusing on how both vaccines help protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study is a phase 3 trial conducted internationally, including the United States and Puerto Rico. Participants are divided into three age groups 15 months to less than 2 years, 2 years to less than 5 years, and 5 years to less than 18 years. Within each group, participants are randomly assigned in a 21 ratio to receive a single injection of either the new PG4 vaccine or the 20vPnC vaccine. The vaccine is administered intramuscularly in the arm or thigh. The study lasts about 6 months and involves 2 clinic visits and 1 telephone follow-up. During the clinic visits, blood samples are taken to measure immune responses and participants are monitored for any side effects or adverse events. Researchers assess local and systemic reactions within 7 days after vaccination, adverse events up to 1 month, and serious adverse events up to 6 months after vaccination. The main outcomes include measuring specific antibody levels to evaluate the immune response. Participants are contacted by phone for a follow-up to check for any further side effects, ensuring ongoing safety monitoring throughout the study.