Bothell

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are collecting and analyzing a wide range of physiological, physical, and molecular data from a diverse group of people to better understand how these factors relate to health and disease. The study aims to identify which foods are linked to improved wellness and which may be associated with decreased wellness. By observing food intake patterns and lifestyle factors alongside non-invasive sample testing, the study hopes to develop personalized diet and lifestyle recommendations. Participants will provide various samples such as stool, blood, saliva, cheek swabs, vaginal samples, breast milk or colostrum, nasal swabs or washes, and urine. These samples are sent to Viome labs or contract research organizations for detailed analysis, including genetic, transcriptomic, metabolomic, physiological, and physical assessments. This observational study does not involve any interventions or treatments. During the study, participants will collect and ship samples while providing information about their food intake and lifestyle. Researchers will monitor molecular determinants of health and disease over a period of 10 years. This long-term observation will help understand the connections between diet, lifestyle, and wellness. Participants can expect to contribute data through sample collection and questionnaires over the study duration.

Researchers are evaluating the effectiveness of Viomes Precision Nutrition Program VPNP in reducing HbA1c levels in adults with diabetes or prediabetes. This randomized, placebo-controlled trial will recruit participants with HbA1c between 5.7% and 8.9% to assess changes in blood sugar control and insulin resistance over approximately 90 days. Participants will be randomly assigned to receive either personalized dietary recommendations and supplements through the VPNP or a placebo. At the start, participants complete online questionnaires and provide blood, stool, and saliva samples both in a lab and at home. After analysis, they follow assigned nutrition plans and take supplements or placebo for 90 days. Throughout the study, participants will complete questionnaires and sample collections again at the end of the 90-day period. Researchers will measure HbA1c, insulin resistance, BMI, cholesterol, waist-to-hip ratio, cardiovascular risk, mental health scores, species prevalence in samples, and fasting glucose. Participants may need to use a mobile app and visit a Quest Diagnostic center for some tests.

This research aims to evaluate the effectiveness of Viomes Precision Nutrition Program VPNP in lowering HbA1c levels in adults with diabetes. This randomized, placebo-controlled trial recruits participants with HbA1c levels between 6.5% and 8.9% to compare personalized nutritional recommendations and supplements against placebo. The study focuses on assessing how these interventions may impact blood sugar control over approximately 90 days. Participants are randomly assigned to either the VPNP group or a placebo group. At the start, they complete online questionnaires and provide samples of blood, stool, and saliva through at-home collection kits sent back to Viome for analysis. After analysis, those in the VPNP group receive tailored dietary advice and personalized supplements, while the placebo group receives inactive capsules. Both groups follow their assigned plans for 90 days, after which they repeat questionnaires and sample collections for comparison. Throughout the study, participants complete assessments including blood tests and questionnaires about health and mood. Researchers monitor HbA1c levels, fasting insulin, BMI, waist-to-hip ratio, cholesterol, cardiovascular risk, mental health scores, and species prevalence in collected samples. Participants may use a mobile app to assist with the program and must be able to visit a diagnostic center for some tests. The total participation time is about three months, with data collected at the start and end of the period to evaluate changes.

Researchers are evaluating the safety and effectiveness of dapansutrile OLT1177 tablets in adults experiencing an acute gout flare. This randomized, double-blind, placebo-controlled Phase 23 study aims to compare dapansutrile to placebo in reducing joint pain and other gout symptoms. The trial focuses on subjects who have had a gout flare starting within 96 hours before the first study visit. Participants will be randomly assigned in a 21 ratio to receive either dapansutrile or a matching placebo. Treatment begins with an initial loading dose on Day 1, followed by twice daily dosing through Day 7. Rescue medication paracetamolacetaminophen is provided at baseline to manage pain after the first assessment. Other pain or anti-inflammatory medications are not allowed during the treatment period. Participants will visit the clinic on Days 4, 8, and 15 for assessments and safety monitoring. Researchers will evaluate joint pain reduction at 72 hours after the initial dose as the primary outcome, along with other signs of gout such as tenderness, swelling, and redness at various time points. Safety data collection continues through Day 36, including physical exams, vital signs, ECGs, lab tests, and adverse event monitoring.

Researchers are studying gastrointestinal health in US residents who have gastrointestinal issues, focusing on irritable bowel syndrome IBS diagnosed by ROME IV criteria with specific symptom scores. The study evaluates the effects of Viome-designed condition-based supplements and the Viome Precision Nutrition Program compared to a placebo. This interventional trial aims to improve clinical outcomes related to gastrointestinal wellness over approximately four months. Participants are randomly assigned to one of three groups a placebo group receiving inert capsules, a group receiving Viomes condition-based supplements tailored to overall health conditions, and a group receiving the Viome Precision Nutrition Program based on microbiome sample results. Each group may receive nutritional supplements, dietary recommendations, and coaching. The study is direct-to-participant and does not involve clinical sites, with some participants using a mobile app to support participation. During the trial, participants complete surveys and follow nutritional guidance as assigned. Researchers monitor the efficacy of both the condition-based supplements and the precision nutrition program over about four months. Participants must adhere to study instructions and use the Viome app as needed. The study assesses symptom improvements and dietary adherence while ensuring safety and participant compliance throughout the trial period.

Researchers are evaluating nutritional programs designed by Viome to improve clinical outcomes for people with metabolic health conditions. This interventional study involves US residents aged 25 to 75 who have obesity and meet specific metabolic criteria. Participants are randomized into one of three groups to compare the effects of placebo supplements, Viomes condition-based supplements, or Viomes Precision Nutrition Program on metabolic wellness symptoms over about 4 months. The study includes three arms one group receives placebo supplements along with nutritional recommendations, the second group receives Viomes condition-based supplements and nutritional guidance, and the third group participates in the Precision Nutrition Program which combines supplements, diet recommendations, and app coaching tailored to the participants microbiome. Participants are asked to take supplements daily and follow dietary advice throughout the trial. Participants will complete surveys upon enrollment and are monitored for approximately 4 months. Researchers will assess the effectiveness of the supplements and nutrition programs in improving metabolic health markers such as fasting insulin and glucose levels. The study is conducted directly with participants without clinical site visits, relying on app use for coaching and adherence tracking. Safety and outcome measures are evaluated during and at the end of the trial period.