Rolling Hills Estates

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effects of a combination treatment of Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) on lung function in adolescents aged 12 to 17 years with asthma that is not well controlled by current treatments. This Phase 3 study compares this three-drug combination with a two-drug combination of FF and VI over a 24-week period to assess their impact on breathing ability and safety. Participants will receive either the FF/UMEC/VI combination or the FF/VI combination, both delivered using the ELLIPTA inhaler device. The treatment will be administered consistently over 24 weeks, with the study designed as a randomized, double-blind, parallel-group trial to fairly compare the two therapies. The goal is to observe differences in lung function and other health effects during this treatment period. During the study, participants will undergo evaluations including lung function tests measuring forced expiratory volume in 1 second (FEV1) at the start and after 24 weeks of treatment. Researchers will monitor safety, tolerability, and how well participants respond to the therapies. The total participation time spans these 24 weeks of treatment, with assessments to track changes and effects throughout the study.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

Researchers are evaluating the effects of KAI-9531, given by weekly subcutaneous injection, compared to a placebo in adults living with obesity who do not have diabetes. This Phase 2b study aims to determine how KAI-9531 impacts body weight over time, specifically measuring the percent change from baseline to week 48. Participants will receive either KAI-9531 or a placebo via subcutaneous injection once a week during the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatment and placebo groups. The main treatment period lasts 48 weeks. During the study, participants will have their body weight measured at baseline and at week 48 to assess changes. Researchers will monitor safety and efficacy throughout the treatment period. The total participation time includes the treatment period and any necessary follow-up visits to track outcomes and ensure participant well-being.

This Phase 3 clinical trial is studying adults with obstructive sleep apnea (OSA) who are overweight or obese and not using positive airway pressure (PAP) therapy. The study aims to evaluate the safety and effectiveness of maridebart cafraglutide compared to a placebo over one year. Participants must have moderate to severe OSA confirmed by sleep testing and a history of unsuccessful weight loss attempts through diet and exercise. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo by subcutaneous injection. The treatment period lasts 52 weeks, during which the effects of the drug on OSA and related symptoms will be monitored. No PAP therapy will be used during the study, and participants must not plan to start PAP treatment while enrolled. Throughout the study, participants will undergo assessments including polysomnography to measure apnea-hypopnea index (AHI), which tracks breathing interruptions during sleep. Researchers will monitor safety, tolerability, and changes in sleep apnea severity from the start to the end of the 52-week treatment. The total duration of participation is one year, allowing for careful evaluation of long-term effects.

This Phase 3 clinical trial is studying adults with obstructive sleep apnea (OSA) who are also overweight or living with obesity. The trial evaluates the safety and effectiveness of maridebart cafraglutide compared to a placebo. All participants are currently using positive airway pressure (PAP) therapy to manage their OSA. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo through subcutaneous injections. The study lasts for 52 weeks, during which participants will continue their PAP therapy. The trial aims to see how maridebart cafraglutide affects OSA symptoms and related health outcomes compared to placebo. During the study, participants will be regularly monitored and assessed, including measuring changes in the apnea-hypopnea index (AHI) from baseline to week 52. Researchers will evaluate safety, tolerability, and the overall impact of the treatment on OSA and weight. The total participation duration is about one year, with ongoing health checks and adherence tracking throughout the trial.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.