220 Participants NeededMy employer runs this trial

ALV-100 for Obesity

(PRESERVE Trial)

Recruiting at 19 trial locations
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alveus Therapeutics, Inc.
Must be taking: Incretin-based therapies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

BMI ≥27 kg/m2 at screening
Willing to maintain their current general diet and physical activity regimen throughout the study
I am between 18 and 75 years old.
See 3 more

Exclusion Criteria

I have been diagnosed with diabetes at some point in my life.
I have had surgery or used a device to treat obesity.
My obesity is caused by a known hormone or genetic disorder.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALV-100 or placebo to assess efficacy, safety, and tolerability for maintenance of weight loss

24 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Follow-up visits until Week 36

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

Group I: Dose C - Schedule 1Experimental Treatment2 Interventions
Group II: Dose B - Schedule 1Experimental Treatment2 Interventions
Group III: Dose A - Schedule 2Experimental Treatment2 Interventions
Group IV: Dose A - Schedule 1Experimental Treatment2 Interventions

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/...

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