PRESERVE
RecruitingPhase 2Study 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
Lead sponsor
Asset
ALV-100
GLP-1 agonist / GIP antagonist
Listed sites
20
Recruiting sites
20
Estimated enrollment
220
Study population
Adults, Obesity / overweight
Eligibility highlights
•BMI ≥23
Primary endpoint
•Dose response of ALV-100
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Eligibility criteria
Key inclusion criteria
1. Adult male and female participants, aged ≥18 to ≤75
2. BMI ≥23 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
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsDose response of ALV-100 as assessed by maintenance of weight loss
Time frame:24 weeks
descriptive
Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss
Time frame:24-36 weeks
descriptive
Glycemic / diabetes
1 endpointChange from baseline in glycemic control parameters
Time frame:24-36 weeks
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange from baseline in lipid parameters
Time frame:24-36 weeks
change from baseline, improvement
Patient-reported / QoL
2 endpointsEfficacy 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
descriptive
Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)
Time frame:24-36 weeks
descriptive
Safety / tolerability / PK
3 endpointsAssess the safety and tolerability of ALV-100
Time frame:36 weeks
descriptive
Change from baseline in vital signs
Time frame:24-36 weeks
change from baseline, event
Immunogenicity of ALV-100
Time frame:36 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.