Kanwal

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating the effectiveness and safety of ribupatide KAI-9531 given as a once-weekly subcutaneous injection compared to semaglutide and placebo for people living with obesity who do not have diabetes. This Phase 3, randomized, partially-blinded study aims to show that ribupatide is superior in reducing body weight. Participants included have a body mass index BMI of 35 kgm or higher and a history of unsuccessful weight loss attempts through diet and exercise in the past 6 months. Participants will be randomly assigned to one of four groups two different doses of ribupatide once weekly, semaglutide once weekly, or a placebo injection once weekly. The study treatment is administered by subcutaneous injection, and the treatment period lasts for 76 weeks. The study compares the percentage change in body weight among these groups and also monitors several other health measures related to weight, metabolism, quality of life, and safety. During the study, participants will have regular visits for assessments including body weight, waist circumference, blood pressure, cholesterol levels, and questionnaires about eating behaviors and quality of life. Researchers will also monitor for any adverse events and test for antibodies against the study drugs throughout the 80-week period. The total participation duration may extend up to 80 weeks, including safety follow-up after the treatment period ends.

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis AD. This Phase 1a1b randomized, double-blind, placebo-controlled study includes healthy participants and those with AD to better understand how TRB-061 behaves in the body and its effects. The study is divided into three parts to assess single and multiple doses in different groups. In Part 1, healthy participants receive a single ascending dose of TRB-061 or placebo and are followed for 12 weeks. Part 2 involves healthy participants receiving three doses of TRB-061 or placebo every four weeks over eight weeks, followed by a 10-week follow-up. Part 3 includes patients with moderate-to-severe AD randomized to receive either one of two doses of TRB-061 or placebo every four weeks for 12 weeks. Participants in Part 3 may opt into a crossover period where treatment assignments are switched for another 12 weeks, followed by a final follow-up until the end of the study. Participants will undergo safety assessments including monitoring of adverse events, pharmacokinetic blood tests, and clinical evaluations throughout the study and follow-up periods. Healthy participants are screened for general health and ECG abnormalities before enrollment, while AD patients must have a confirmed diagnosis and moderate-to-severe disease. Regular visits are scheduled for dosing and evaluations, and researchers will measure safety outcomes primarily by tracking adverse events from screening through follow-up. The study aims to complete by February 2028.

Researchers are evaluating the effect of MAR001 compared to a placebo in adults with elevated triglycerides TG and remnant cholesterol RC. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how MAR001 influences TG levels in participants with these conditions. The study includes two parts with different participant groups based on their baseline TG levels. Participants are assigned randomly to receive either MAR001 or placebo through subcutaneous injections every 4 weeks. Part A includes about 216 participants with baseline TG between 150 to 880 mgdL, treated with three different doses of MAR001 or placebo at a 31 ratio. Part B enrolls around 100 participants with baseline TG between 450 and 2000 mgdL, using the dose selected from Part A data, assigned at a 11 ratio. The study timeline consists of up to 8 weeks of screening, a 24-week treatment period, and a 12-week safety follow-up with clinic visits at weeks 28 and 36. During the study, participants will undergo assessments including blood tests and clinical evaluations to monitor TG and RC levels and safety outcomes. The primary outcome is measured at 12 weeks, with additional secondary outcomes assessed at various time points. Participants adherence to stable diet and medication regimens is monitored. The total participation duration extends through the screening, treatment, and follow-up periods, with safety monitored until study completion.