GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices

A Phase 1, Randomized, Open-label, Single-Dose, Crossover Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-9531 Subcutaneous Injection in Participants With a Range of Body Mass Indices

Lead sponsor

Kailera

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-40•Healthy volunteers

Primary endpoints

•Cmax of KAI-9531•AUC From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531•AUC From 0 to Infinity (AUC0-inf) of KAI-9531

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 IDNCT07044401

Org study IDK9531-1102

Timeline

Milestones

Study first posted2025-07-01actual

Study start2025-07-14actual

Primary completion2025-11-13actual

Study completion2025-11-13actual

Last update posted2025-12-05actual

Assets

Investigational agents

HRS9531

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body mass index (BMI) ≥ 25.0 and ≤ 40.0 kilograms per square meter (kg/m^2), with a body weight ≤ 120 kg.

•Medically healthy.

Exclusion criteria

•Known hypersensitivity to the study drug or any of the study drug ingredients.

•History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder.

•Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).

•Estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

•Glycosylated hemoglobin (HbA1c) test result ≥6.5%.

•A history of or positive test results at the Screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (HCVab) with HCV ribonucleic acid (RNA) confirmation if positive.

•Positive drugs of abuse or alcohol test results.

•Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer).

•Any other condition or prior therapy that would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Maximum Observed Concentration (Cmax) of KAI-9531

Time frame:Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531

Time frame:Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531

Time frame:Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Time frame:Day 1 to Day 113

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Experience a Serious Adverse Event (SAE)

Time frame:Day 1 to Day 113

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Experience Antidrug Antibodies to KAI-9531

Time frame:Day 1 to Day 113

Immunogenicity (ADA)

event count, event

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.