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NCT07044401CompletedPhase 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

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

The main objective of the study is to assess the relative bioavailability of KAI-9531 subcutaneous (SC) injection in the upper arm and thigh compared to the abdomen.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
51 (actual)
First submitted
23 Jun 2025
Start date
14 Jul 2025
Primary completion date
13 Nov 2025
Lead sponsor
Kailera
Diseases
Obesity
NCT number
NCT07044401

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 51
  • From 14 Jul 2025 to the primary completion date, 13 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).
  • 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.

Lab values

  • 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%.

Who the study is looking for

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

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Celerion
Coordinator of this site? Confirm its status
TempeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.