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Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

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.

Crohn's Disease (CD) is a gastrointestinal condition that can cause chronic diarrhea, abdominal pain, weight loss, and fever. This study is evaluating the pharmacokinetics, effectiveness, and safety of risankizumab in children aged 2 to less than 18 years with moderately to severely active CD who have not responded well or are intolerant to other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is being studied here for pediatric CD in a Phase 3 trial. The study includes three groups (cohorts) based on age ranges: 6 to less than 18 years, 2 to less than 6 years, and 2 to less than 18 years. Participants start with an open-label induction period where they receive intravenous risankizumab over 12 weeks. Next, in a double-blind maintenance period lasting 52 weeks, they receive subcutaneous risankizumab at one of two doses. Following this, there is an open-label extension phase of 208 weeks with ongoing subcutaneous risankizumab treatment. Participants will visit hospitals or clinics regularly for medical assessments including blood tests, monitoring for side effects, and questionnaires to evaluate treatment effects. The study will measure outcomes such as clinical remission rates and endoscopic response at 64 weeks. Safety and how the drug moves through the body will also be tracked for up to about 64 weeks, with a follow-up period of approximately 140 days. The total involvement may involve higher treatment burden compared to usual care.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

Researchers are evaluating the effectiveness and safety of standard chemotherapy alone or combined with INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma (PDAC) with a KRAS G12D mutation. This phase 3, randomized, double-blind study focuses on individuals who have not received prior treatment for metastatic PDAC. The goal is to understand if adding INCB161734 to chemotherapy improves outcomes in this group of patients. Participants will receive either oral INCB161734 tablets or a placebo, along with a chemotherapy regimen selected by the investigator following specific protocol requirements. The chemotherapy options are defined by the study protocol. Treatments will be administered as planned during the study period, with careful monitoring to assess their effects. Throughout the study, participants will be monitored for overall survival up to approximately three years, progression-free survival, and objective tumor response assessed up to about two years. Researchers will conduct regular evaluations including clinical assessments and imaging reviewed by blinded independent central review (BICR). Safety and efficacy data will be collected to understand the impact of the treatments over time.

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are studying the effectiveness, safety, and tolerability of ponsegromab combined with standard chemotherapy compared to chemotherapy with placebo in adults who have cachexia and metastatic pancreatic ductal adenocarcinoma. This Phase 2b/3 study includes participants who have already completed initial chemotherapy cycles and aims to evaluate ponsegromab as a first-line treatment option for this condition. The study includes a randomized, double-blind design conducted across multiple centers and countries. Participants will receive either one of two doses of ponsegromab or a placebo, both given alongside standard chemotherapy regimens such as nab-paclitaxel plus gemcitabine or FOLFIRINOX. The study intervention is administered subcutaneously every four weeks. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants may continue or switch doses accordingly while maintaining blinding. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind study period. During the study, participants will undergo tumor assessments every 6 to 8 weeks by independent radiologists. Researchers will measure body weight changes and anorexia symptoms over 12 weeks to assess treatment impact. The study also includes a caregiver sub-study to explore the quality of life and well-being of primary caregivers. Treatment continues until discontinuation, withdrawal, death, or study completion based on overall survival events.