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PRESERVE

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

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

NCT IDNCT07837973
Org study IDALV-101-1

Timeline

Milestones

Study start2026-08-10actual
Study first posted2026-09-24actual
Last update posted2026-10-26actual
Primary completion2027-08-24estimated
Study completion2027-08-24estimated

Assets

Investigational agents

Who this study enrolls

AdultsObesity / overweight

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Safety / tolerability / PK
3
Weight & body composition
2
Patient-reported / QoL
2
Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Dose response of ALV-100 as assessed by maintenance of weight loss

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

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

Time frame:24-36 weeks

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from baseline in glycemic control parameters

Time frame:24-36 weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from baseline in lipid parameters

Time frame:24-36 weeks

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Assess the safety and tolerability of ALV-100

Time frame:36 weeks

descriptive

Secondary/protocol endpoint

Change from baseline in vital signs

Time frame:24-36 weeks

change from baseline, event

Secondary/protocol endpoint

Immunogenicity of ALV-100

Time frame:36 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.