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NCT Number: NCT07837973

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

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.

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Key information

Conditions

Overweight , Obesity Adults Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

ALV-100

Drug

Experimental drug

Placebo

Drug

Volume matched placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Assess the safety and tolerability of ALV-100

    Time frame: 36 weeks

    Incidence of treatment emergent adverse events (TEAE) from first dose administration until Week 36

  2. Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss

    Time frame: 24-36 weeks

    Percentage change from baseline to week 24 and to Week 36 in Body Weight. Change from baseline to Week 24 and to Week 36 in BW (kg). Participants with a percentage change in BW from baseline to week 24 and to Week 36 of ≤3 %

  3. Change from baseline in glycemic control parameters

    Time frame: 24-36 weeks

    Change from baseline in fasting glucose and hemoglobin A1c (HbA1c). Fasting glucose will be measured in mg/dL or mmol/L and HbA1c will be measured as percentage (%) or mmol/mol.

  4. Change from baseline in lipid parameters

    Time frame: 24-36 weeks

    Change from baseline in total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, VLDL-cholesterol, triglycerides, and free fatty acids (FFA), measured in mg/dL or mmol/L.

  5. Change from baseline in vital signs

    Time frame: 24-36 weeks

    Change from baseline in systolic and diastolic blood pressure, measured in mmHg.

  6. Immunogenicity of ALV-100

    Time frame: 36 weeks

    Incidence of anti-drug antibodies (ADA) from baseline (pre-dose) until Week 36

  7. Efficacy of ALV-100 versus placebo on subjective control of eating, food cravings, and mood-related eating behaviors as assessed by the Control of Eating Questionnaire (CoEQ)

    Time frame: 24-36 weeks

    Change from baseline in total and subscale scores of the Control of Eating Questionnaire (CoEQ) which is a 19-item patient-reported outcome measure that assesses aspects of eating behavior, including hunger, satiety, food cravings, craving control, and mood. Items are rated on an 11-point numeric rating scale from 0 to 10. The CoEQ includes four subscales: Craving Control (5 items), Positive Mood (4 items), Craving for Sweet Foods (4 items), and Craving for Savoury Foods (4 items), as well as single-item assessments of hunger and satiety. Subscale scores are calculated as the mean of the applicable item scores and range from 0 to 10. Higher Craving Control scores indicate greater control over food cravings, while higher craving scores indicate greater food cravings.

  8. Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)

    Time frame: 24-36 weeks

    Change from baseline in total scores of the FOOD Noise Questionnaire (FNQ). The Food Noise Questionnaire (FNQ) is a 5-item patient-reported outcome measure designed to assess persistent and intrusive thoughts about food that may interfere with daily life. Each item is rated on a 5-point Likert scale from 0 (strongly disagree) to 4 (strongly agree). The total score is calculated by summing the responses to the 5 items and ranges from 0 to 20. Higher scores indicate greater levels of food noise.

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Recruiting

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Sponsors and collaborators

Lead sponsor

Alveus Therapeutics, Inc.

Industry

Registry information

Official study title

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 on Semaglutide

Acronym: PRESERVE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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