GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US

A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US

Lead sponsor

Regeneron Pharmaceuticals

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-45

Primary endpoints

•Treatment-emergent AEs (any)•Cmax•AUC from time 0

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07431086

Org study IDHS-20094-OB-2569

Timeline

Milestones

Study first posted2026-02-24actual

Study start2026-03-16actual

Last update posted2026-04-29actual

Primary completion2026-11-23estimated

Study completion2026-12-28estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

1. Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening

2. Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment

Key Exclusion Criteria:

1. History of Type 1 or Type 2 diabetes

2. Change in body weight >5 kg within approximately 3 months before screening as described in the protocol

3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period

4. History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Endpoints (16)

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

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent change in body weight

Time frame:From baseline to week 25

Body weight, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)

Time frame:From baseline to weeks 7, 15 and 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in in-clinic SBP

Time frame:From baseline to weeks 7, 15 and 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:Up to approximately 30 weeks

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Severity of TEAEs

Time frame:Up to approximately 30 weeks

Treatment-emergent AEs (any)

descriptive

Primary/protocol endpoint

Maximum plasma Concentration (Cmax)

Time frame:At week 15 and week 24

Cmax

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)

Time frame:At week 15 and week 24

concentration, descriptive

Secondary/protocol endpoint

Lowest concentration in a dosing interval (Ctrough)

Time frame:Up to approximately 30 weeks

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (Tmax)

Time frame:Up to approximately 30 weeks

Tmax

descriptive

Secondary/protocol endpoint

Apparent Volume of distribution (Vd/F)

Time frame:Up to approximately 30 weeks

descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:Up to approximately 30 weeks

descriptive

Secondary/protocol endpoint

Apparent terminal half-life (t½)

Time frame:Up to approximately 30 weeks

Half-life

descriptive

Secondary/protocol endpoint

Olatorepatide concentrations

Time frame:Up to approximately 30 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

Time frame:Up to approximately 30 weeks

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Magnitude of ADA to olatorepatide

Time frame:Up to approximately 30 weeks

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Corrected QT interval using the Fridericia formula (QTcF)

Time frame:Pre-dose to up to 48 hours post-dose

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 July 1, 2026 snapshot.