Stamford

Researchers are studying whether the medicines calderasib and subcutaneous pembrolizumab can be used together to treat non-small cell lung cancer NSCLC in people with a specific KRAS G12C mutation. The main goal is to find out if patients receiving calderasib plus pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. Participants will be randomly assigned to one of two groups one group will receive pembrolizumab and berahyaluronidase alfa as a subcutaneous injection every 6 weeks for up to about 2 years plus calderasib pills daily until treatment needs to stop. The other group will receive the same pembrolizumab and berahyaluronidase alfa injections plus chemotherapy drugs pemetrexed with either carboplatin or cisplatin delivered by intravenous infusion at specific days during the treatment cycles. Throughout the study, participants will be closely monitored for how long they live without cancer progression, overall survival, response to treatment, and quality of life using questionnaires and other assessments. The study will track side effects and any reasons for stopping treatment over several years, with evaluations continuing for up to about 81 months. This long-term follow-up helps researchers understand the safety and impact of these treatments over time.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer mNSCLC whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1 or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy carboplatin or cisplatin and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices ISAs that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are investigating treatments for obesity or overweight in children and teenagers aged 6 to 17. This phase 3 pediatric chronic weight management study aims to create a framework to evaluate the safety and effectiveness of medicines for managing weight in this young population. The study is designed as a master protocol, allowing multiple interventions to be tested independently as they become available. Participants will be randomly assigned to receive either the drug Orforglipron or a placebo, both given by mouth. Each intervention will follow specific details within the study arms. The study periods include enrollment under the master protocol and independent substudies for each intervention. Results will be reported when all intervention substudies are completed. Throughout the study, participants will have regular assessments to monitor their weight and health. Researchers will track the number of participants assigned to each intervention from the start through week 72. The study includes evaluations of safety and effect on body weight, with ongoing monitoring to understand the impact of the treatments. Total participation may last up to about 72 weeks, with periodic visits and evaluations.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the long-term safety of buntanetap in people with Parkinsons Disease PD through a 36-month open-label safety study. The trial includes two groups one with participants previously involved in buntanetap trials and another with participants receiving deep brain stimulation DBS treatment. This study focuses on safety, monitoring side effects and adverse events during the treatment period. Participants will receive a daily oral dose of buntanetap 30 mg after a screening period of up to 42 days. Cohort 1 participants stop their usual Parkinsons medications 12 hours before baseline and annual visits to ensure an OFF state during assessments. Cohort 2 participants, who have had DBS surgery, will also stop standard medications 12 hours before visits and reset their DBS settings to baseline the night before key visits. Throughout the study, participants will undergo assessments including cognitive and motor function tests such as MMSE, MoCA, C-SSRS, and MDS-UPDRS by trained clinicians. They will be monitored for adverse events, treatment safety, and treatment-emergent side effects over the 36 months. Participants must have a support person for visits, and safety will be closely observed to ensure well-being during the trial.

Researchers are evaluating the combination of calderasib and pembrolizumab as a first-line treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50 or higher. This Phase 3 study aims to compare this combination against pembrolizumab with a placebo to see if it improves progression-free survival and overall survival. Participants are randomly assigned to receive pembrolizumab 200 mg via intravenous infusion every 21 days for up to 35 cycles, combined either with oral calderasib tablets or with a placebo taken daily until the treatment needs to be stopped. The study is double-blind, meaning neither the participants nor the researchers know which treatment is given, to ensure unbiased results. During the study, participants will be closely monitored with regular assessments to track cancer progression, survival, response to treatment, and quality of life using specialized questionnaires. Safety will be evaluated by recording any adverse events and treatment discontinuations. The main outcomes will be observed for up to approximately 42 months for progression-free survival and up to 56 months for overall survival, with quality of life assessments continuing for about 24 months.