Minneapolis

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating the use of letermovir to prevent cytomegalovirus (CMV) infection in children and adolescents who have received a kidney transplant and weigh less than 40 kilograms. This phase 1 study aims to understand how letermovir behaves in the body over time and to assess its safety and tolerability in this young population. Participants between 4 and 52 weeks after their kidney transplant will receive letermovir orally, either as tablets or pellets, or through a gastrostomy or nasogastric tube, for 7 consecutive days. The study is open-label and single-arm, focusing on weight-based dosing of letermovir. Throughout the study, researchers will monitor the drug levels in the body by measuring the area under the curve from dosing up to 24 hours on day 7. They will also track any adverse events up to 21 days and note if anyone stops the study drug due to side effects within 7 days. Participants will be assessed for kidney function stability and absence of CMV infection, with careful follow-up to evaluate the drug's safety and how well it is tolerated.

Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are investigating the maximum safe dose of Levetiracetam (LEV) for treating seizures in newborns. This Phase IIb study focuses on infants with mild to moderate neonatal seizures, hypothesizing that the optimal dose is higher than the current 60 mg/kg. The research also explores LEV's safety, tolerability, and its effectiveness compared to the standard treatment, Phenobarbital (PHB). Participants initially receive 60 mg/kg of LEV. If seizures continue after 15 minutes, they may be randomly assigned to receive either higher doses of LEV (in increments up to 150 mg/kg total) or PHB treatment at 20-40 mg/kg. The study uses continuous video EEG monitoring to measure seizure activity and evaluate the treatments. The trial includes multiple phases and dose escalation to ensure safety and gather efficacy data. During the study, infants will undergo continuous EEG monitoring to assess seizure burden over 24 hours, with neurophysiologists reviewing the data. Researchers will track LEV blood levels, adverse events, seizure reduction, and long-term outcomes up to 8 years. The study also evaluates a seizure detection technology. Participation involves treatment administration, monitoring, and follow-up to assess safety and seizure control.

Researchers are evaluating the safety of aerosolized RSP-1502, a drug containing tobramycin and CaEDTA, in people with cystic fibrosis who have chronic lung infections caused by Pseudomonas aeruginosa. This phase 1b/2a study compares different doses of RSP-1502 to an active control treatment to find the highest tolerated dose and assess safety. The study is double-blind, meaning neither participants nor researchers know who receives which treatment during the study. Participants will inhale RSP-1502 or the active control, which is tobramycin inhalation solution, over 14 days. The study includes dose escalation cohorts receiving increasing doses of RSP-1502 combined with a fixed dose of tobramycin, followed by a dose expansion cohort at the maximum tolerated dose (MTD). Treatments are delivered via a nebulizer device designed to administer the medication directly to the lungs. During the study, participants will undergo evaluations including spirometry tests, electrocardiograms, and monitoring for any adverse events from Day 1 through Day 28, which covers the 14 days of treatment and 14 days of follow-up after dosing. Researchers will also analyze drug levels in the body at various time points and monitor for lung exacerbations and safety signals. The total participation period is 28 days per participant.

Researchers are studying the safety, tolerability, and how the body processes and responds to IMP1734, a PARP1 selective inhibitor, in adults with advanced solid tumors. This trial focuses on patients with recurrent or metastatic cancers such as breast, ovarian, and prostate cancer. The study aims to find the best dose and understand early effects of IMP1734 when used alone, addressing treatment options for these advanced cancers. The trial includes two parts: Part 1 involves increasing doses of IMP1734 alone to find the maximum tolerated or achievable dose. This includes patients with metastatic prostate cancer, ovarian, and breast cancer. Part 2 will explore the best dose for future studies. IMP1734 is given as oral tablets daily, except during a single-dose period. Participants may be involved for up to three years after their first treatment. During the study, participants will have regular assessments for safety including monitoring adverse events and tolerability. Researchers will evaluate pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug's effects). They will also measure tumor response and other clinical outcomes. Follow-up will continue up to three years to monitor long-term effects and gather comprehensive data on IMP1734.

Researchers are studying people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity (FVC), over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatment's long-term safety and effects.

Researchers are evaluating the effectiveness and safety of volrustomig compared to observation in adults with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). This phase III global study focuses on patients with specific stages of LA-HNSCC and aims to better understand treatment options after initial therapy. Participants are randomly assigned to one of two groups: one group receives volrustomig, a drug being studied, while the other group is placed under observation without additional treatment. The study is open-label and conducted at multiple centers worldwide. The treatment or observation period follows the completion of definitive cCRT with curative intent. During the study, participants undergo regular assessments to monitor progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also track the presence of anti-drug antibodies and measure drug concentrations in blood samples. Safety is monitored by recording adverse events over a period of up to approximately 8 years, allowing long-term evaluation of outcomes and participant well-being.

Researchers are evaluating the safety and effectiveness of combining durvalumab with domvanalimab compared to durvalumab with a placebo in adults who have locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) that has not worsened after platinum-based concurrent chemoradiotherapy. This Phase III, randomized, double-blind, placebo-controlled international study aims to understand if adding domvanalimab improves outcomes in this patient group. Participants will receive either durvalumab plus domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, starting on Day 1, for up to 12 months. The study includes two groups: one receiving the experimental combination and the other receiving durvalumab with placebo. The treatment phase spans a maximum of one year. During the study, participants will be closely monitored through various assessments including tumor tissue analysis and performance status evaluations. Researchers will measure progression-free survival up to 8 years after randomization as the main outcome. Additional outcomes include overall survival, response rates, duration of response, and safety markers. The study involves long-term follow-up to assess durability of outcomes and treatment effects.