RightFit
RecruitingPhase 2

Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss

A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously Treated With Incretin-Based Therapies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well ALV-100 helps people keep weight off and how safe it is. It is for adults with overweight or obesity who lost at least 10% of their body weight while taking incretin-based medicines, which act like gut hormones.

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 incretin-based therapies.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old.
  • Have a BMI of 27 or higher at screening. BMI is a measure of weight compared to height.
  • Have taken an incretin-based weight-loss medicine at the same dose for at least 3 months in a row before screening.
  • Are able to handle the incretin-based medicine, as judged by the study doctor.
  • Lost at least 10% of your body weight on that medicine, and your weight has stayed steady for at least 3 months before screening.
  • Are willing to keep your current general eating and exercise habits during the study.

Who can't join

  • Have ever had type 1 or type 2 diabetes.
  • Have had surgery or used a weight-loss device to treat obesity.
  • Have obesity caused by certain hormone disorders, disease in a brain area called the hypothalamus, or certain genetic conditions.
  • Take, or took within 3 months before screening, medicines that may cause major weight gain.
  • You or a family member have had medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN 2), a condition that causes tumors in hormone-making glands.
  • Have cancer now or have had cancer within the 5 years before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key inclusion criteria 1. Adult male and female participants, aged ≥18 to ≤75 2. BMI ≥27 kg/m2 at screening. 3. Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening. 4. Tolerating incretin-based therapy at the discretion of the investigator 5. WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening. 6. Willing to maintain their current general diet and physical activity regimen throughout the study. Key exclusion criteria 1. Lifetime history of Type 1 or Type 2 diabetes 2. Prior obesity treatment with surgery or a weight loss device. 3. Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity. 4. Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain. 5. Family or personal history of MTC or MEN 2 6. Presence or history of malignant neoplasms within the past 5 years prior to screening

Study sites (20)

AL

AZ

CA

FL

GA

IL

LA

MI

NC

NY

OK

TN

TX

UT