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Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjgren Syndrome pSS, a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mgkg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjgrens disease, with safety and immune response also closely observed until Day 211.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.