Idaho Falls

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are investigating the effects of multiple doses of vosoritide and comparing its therapeutic dose to human growth hormone (hGH) in children with idiopathic short stature (ISS). This Phase 2 study aims to understand how these treatments influence growth in this population. After an initial observation period of at least 6 months to measure baseline growth, participants are randomly assigned to receive either vosoritide, placebo, or hGH (the latter only in the United States). Those in the vosoritide and placebo groups undergo up to 6 months of randomized treatment, followed by open-label vosoritide until they reach near-final adult height or at least age 16 for females or 18 for males. Participants assigned to hGH receive open-label treatment for a minimum of 4 years. Throughout the study, safety is carefully monitored with clinical and imaging assessments focused on hips and lower extremities, as well as watching for hypotension, fractures, and slipped capital femoral epiphysis. An independent Data Monitoring Committee reviews safety data regularly. Study visits include a treatment completion visit about 4 weeks after the last dose, and follow-up assessments may continue annually through the end of the study. Key outcome measures include changes in annualized growth velocity at 6 months and changes in height and height Z-score after 4 years.

Researchers are evaluating the safety, tolerability, and immune response duration of a second dose of the RSVpreF vaccine given during later pregnancies. The study also examines how long immunity lasts from a single dose given during a previous pregnancy by analyzing blood samples from nonpregnant participants who had the vaccine before. This is a Phase 3 trial focused on pregnant women and their babies as well as nonpregnant women previously vaccinated. Pregnant participants are grouped into Cohort 1, who previously received RSVpreF in a Pfizer trial and will get a second dose, and Cohort 2, who received RSVpreF previously via commercial or trial means and will be randomly given either RSVpreF or placebo. Both groups will be monitored for safety and immune response. Cohort 3 includes nonpregnant women who had RSVpreF before and will provide blood samples to check how long protection lasts, without receiving further vaccination. Participants will undergo safety monitoring during pregnancy and after birth. Infants will be followed for six months to assess safety and antibody levels. Blood tests will measure immune response, including neutralizing antibodies at birth. The study tracks local and systemic reactions, adverse events, serious adverse events, and new medical conditions in both pregnant participants and their infants over various timeframes throughout the study.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the safety and effectiveness of vonoprazan 20 mg taken once daily compared to a placebo in adults with eosinophilic esophagitis (EoE). The main goal is to see how many participants achieve a peak eosinophil count of less than 15 eosinophils per high-power field in the esophagus after 12 weeks of treatment. This is a Phase 2, randomized, double-blind study involving adult participants with EoE. Participants will receive either vonoprazan 20 mg tablets or matching placebo tablets taken orally once daily. The study includes a primary treatment period of 12 weeks, with an additional evaluation of vonoprazan safety and efficacy up to 24 weeks. Treatment is closely monitored to assess the effects on esophageal inflammation. During the study, participants will be monitored through endoscopic biopsies to measure eosinophil counts in the esophagus. They will also complete electronic diaries to document symptoms like dysphagia. Safety assessments and other clinical evaluations will be conducted throughout the study. The primary outcome is the number of participants achieving the target eosinophil count at week 12, with ongoing monitoring to ensure safety and compliance.

Researchers are conducting a Phase 1 clinical trial to evaluate the safety and tolerability of Amicidin-β topical solution when applied directly into infected surgical or traumatic wounds during surgery. The study aims to determine if the solution is safe for further testing, whether it is absorbed into the bloodstream from the wound, and if it is easy for surgeons to use. Participants will have either standard wound care alone or standard care combined with Amicidin-β topical solution to manage their wound infection. The study will include approximately 44 patients divided into three groups of 8, 12, and 24 patients. Within each group, participants will be randomly assigned to receive either standard of care alone or standard of care plus Amicidin-β topical solution, with a ratio of 1:3. The solution is applied locally during the surgical treatment of the infected wound. The trial involves two different solution volumes, 15 mL and 50 mL, to evaluate safety and ease of use. Participants will be monitored from Day 1 to Day 30 for treatment emergent adverse events, comparing those receiving Amicidin-β with those receiving only standard care. Assessments will include tracking any side effects, measuring absorption into the bloodstream, and evaluating wound healing. The total study duration for each participant is about 30 days, during which safety and tolerability will be carefully observed.

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 studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Researchers are evaluating the immune response and safety of an investigational chickenpox vaccine and a marketed measles, mumps, and rubella (MMR) vaccine when given to healthy children aged 12 to 15 months. This Phase 3a study compares the investigational varicella vaccine given as a muscle injection to Merck's chickenpox vaccine administered just under the skin. The study also looks at the immune response and safety of giving these GSK vaccines together with other routine childhood vaccines via muscle injection. Participants receive either the investigational varicella vaccine by intramuscular injection or the marketed varicella vaccine given subcutaneously. The MMR vaccine is administered either subcutaneously or intramuscularly. Other vaccines such as Hepatitis A vaccine, 13-valent, 15-valent (Vaxneuvance), or 20-valent pneumococcal conjugate vaccines may be co-administered intramuscularly depending on country recommendations and availability. During the study, researchers will measure immune responses by assessing antibodies to varicella zoster virus and MMR antigens at Day 43 after vaccination. They will also monitor safety and tolerability throughout the study period. Parents or legal representatives complete diaries and return for follow-up visits to support ongoing safety and immunogenicity assessments. Overall, the study aims to understand how well the vaccines work and how safe they are when given to young children in this age group.