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Scientists compare belly, arm, and thigh shots for new drug

NCT ID NCT07044401

Knowledge-focused Sponsor: Kailera Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how giving a single shot of the experimental drug KAI-9531 in different places (upper arm, thigh, or belly) changes the amount of drug that gets into the blood. It involved 51 healthy volunteers with a range of body sizes. The goal was to find the best injection spot for future studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

51 people

The number who actually took part.

Started

Jul 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Celerion

    Tempe, Arizona, 85283, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.