NCT07837973 · Alveus Therapeutics, Inc.
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
(PRESERVE)
What this study is about
A study of ALV-100 to assess effectiveness, safety and how well patients handle the treatment among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with semaglutide.
View original scientific description
A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with semaglutide.
Interventions
DRUG
ALV-100
Experimental drug
DRUG
Placebo
Volume matched placebo
Primary outcome measures
Dose response of ALV-100 as assessed by maintenance of weight loss
Time frame: 24 weeks
Percentage change from baseline to Week 24 in BW
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult male and female participants, aged ≥18 to ≤75
- BMI ≥27 kg/m2 at screening.
- Has been treated with semaglutide for weight management at a stable dose for at least 3 continuous months prior to screening.
- Tolerating semaglutide at the discretion of the investigator
- WL of at least 10% while on semaglutide and with stable BW for at least 3 months prior to screening.
- Willing to maintain their current general diet and physical activity regimen throughout the study. Key
Exclusion criteria
- Lifetime history of Type 1 or Type 2 diabetes
- Prior obesity treatment with surgery or a weight loss device.
- Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.
- Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.
- Family or personal history of MTC or MEN 2
- Presence or history of malignant neoplasms within the past 5 years prior to screening
Where
- Birmingham, Alabama
- Tempe, Arizona
- Oceanside, California
- Orlando, Florida
- Champaign, Illinois
- Gretna, Louisiana
- Farmington Hills, Michigan
- New York, New York
- Wilmington, North Carolina
- Oklahoma City, Oklahoma
- Nashville, Tennessee
- South Jordan, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations