ALV-100 for Obesity
(PRESERVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ALV-100, a new treatment for individuals with overweight or obesity who have already lost at least 10% of their body weight using incretin-based therapies. The trial aims to evaluate the effectiveness and safety of ALV-100. Participants will receive varying doses of ALV-100 or a placebo to determine the most effective dose. This trial suits those maintaining their weight loss, who have used incretin-based weight management treatments for at least three months, and who are willing to continue their current diet and exercise routine. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must have been on a stable dose of incretin-based therapy for at least 3 months before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that ALV-100 is likely to be safe for humans?
Research has shown that ALV-100 is generally well-tolerated, as earlier studies indicate. Most participants experienced only mild side effects, meaning the treatment did not cause serious health issues for most people. The current trial is in the middle phase, suggesting that initial tests have demonstrated ALV-100's safety for broader testing. This further supports its safety for human use. While no treatment is without risk, the data so far appears promising for those considering joining the trial.12345
Why do researchers think this study treatment might be promising for obesity?
Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, and surgeries such as gastric bypass, ALV-100 stands out for several reasons. Researchers are particularly excited about ALV-100 because it may work through a novel mechanism of action, potentially targeting metabolic processes differently than current medications. Additionally, the treatment's distinctive dosing schedules could offer more personalized and adaptable options for patients, potentially improving adherence and outcomes. This innovative approach could provide a new avenue for tackling obesity beyond the traditional methods currently available.
What evidence suggests that ALV-100 might be an effective treatment for obesity?
Research has shown that ALV-100 could help treat obesity. Early studies found that it can improve metabolism, suggesting a new approach to obesity treatment. In this trial, participants will receive different doses of ALV-100 to evaluate its effectiveness. People who have used other treatments like semaglutide have successfully maintained significant weight loss, and ALV-100 aims to enhance this effect. By focusing on individuals who have already lost weight and maintained it, ALV-100 might help sustain these long-term benefits. Although studies with people are ongoing, these early results are promising for its role in managing obesity.56789
Are You a Good Fit for This Trial?
This trial is for children and adults with overweight or obesity who have already lost at least 10% of their body weight using semaglutide. Participants should be generally healthy aside from their weight history.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ALV-100 or placebo to assess efficacy, safety, and tolerability for maintenance of weight loss
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALV-100
Trial Overview
The study compares a new drug, ALV-100, to a placebo (inactive treatment) to see if it helps people maintain their weight loss after stopping semaglutide. Participants are randomly assigned to either group.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive ALV-100 or volume matched placebo during the treatment period
Participants will receive ALV-100 or volume matched placebo during the treatment period
Participants will receive ALV-100 or volume matched placebo during the treatment period
Participants will receive ALV-100 or volume matched placebo during the treatment period
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alveus Therapeutics, Inc.
Lead Sponsor
Citations
https://www.springermedicine.com/link?doi=10.1186/...
No information is available for this page.
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