Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

May 7, 2026 updated by: Kailera

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Auckland
      • Silverdale, Auckland, Australia, 0932
        • Recruiting
        • Kailera Clinical Site
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Recruiting
        • Kailera Clinical Site
      • Sydney, New South Wales, Australia, 2228
        • Recruiting
        • Kailera Clinical Site
      • Sydney, New South Wales, Australia, 2100
        • Recruiting
        • Kailera Clinical Site
      • Sydney, New South Wales, Australia, 2019
        • Recruiting
        • Kailera Clinical Site
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Kailera Clinical Site
    • Queensland
      • Sippy Downs, Queensland, Australia, 4556
        • Recruiting
        • Kailera Clinical Site
    • South Australia
      • Norwood, South Australia, Australia, 5067
        • Recruiting
        • Kailera Clinical Site
    • Victoria
      • Melbourne, Victoria, Australia, 3025
        • Recruiting
        • Kailera Clinical Site
  • New Zealand
      • Auckland, New Zealand, 0610
        • Recruiting
        • Kailera Clinical Site
      • Nelson, New Zealand, 7011
        • Recruiting
        • Kailera Clinical Site
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Recruiting
        • Kailera Clinical Site
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3200
        • Recruiting
        • Kailera Clinical Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • Kailera Clinical Site
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Kailera Clinical Site
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Kailera Clinical Site
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Kailera Clinical Site
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Kailera Clinical Site
      • Toluca Lake, California, United States, 91602
        • Recruiting
        • Kailera Clinical Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Kailera Clinical Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Recruiting
        • Kailera Clinical Site
    • Florida
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Kailera Clinical Site
    • Georgia
      • Lilburn, Georgia, United States, 30047
        • Recruiting
        • Kailera Clinical Site
    • Illinois
      • Springfield, Illinois, United States, 62072
        • Recruiting
        • Kailera Clinical Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Recruiting
        • Kailera Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Kailera Clinical Site
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Kailera Clinical Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Kailera Clinical Site
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Recruiting
        • Kailera Clinical Site
    • South Carolina
      • Mauldin, South Carolina, United States, 29662
        • Recruiting
        • Kailera Clinical Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37405
        • Recruiting
        • Kailera Clinical Site
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Kailera Clinical Site
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Kailera Clinical Site
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Kailera Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Kailera Clinical Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Recruiting
        • Kailera Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:

    1. hypertension,
    2. dyslipidemia,
    3. obstructive sleep apnea, or
    4. cardiovascular (CV) disease.
  • History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Exclusion Criteria:

  • Current diagnosis or history of diabetes mellitus.
  • Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
  • Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
  • Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
  • Uncontrolled hypertension or unstable cardiovascular disease.
  • History of chronic or acute pancreatitis.
  • Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
  • History of suicide attempt.
  • History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
  • Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KAI-9531: Dose 1
Participants will receive Dose 1 of KAI-9531 once weekly.
Drug: KAI-9531
SC Injection
Placebo Comparator: Placebo
Participants will receive placebo matched to KAI-9531 once weekly.
Drug: Placebo
SC Injection
Experimental: KAI-9531: Dose 2
Participants will receive Dose 2 of KAI-9531 once weekly.
Drug: KAI-9531
SC Injection
Experimental: KAI-9531: Dose 3
Participants will receive Dose 3 of KAI-9531 once weekly.
Drug: KAI-9531
SC Injection
Experimental: KAI-9531: Dose 4
Participants will receive Dose 4 of KAI-9531 once weekly.
Drug: KAI-9531
SC Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time Frame: Baseline, Week 76
Baseline, Week 76

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Waist Circumference
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to Week 80
Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: Up to Week 80
Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Time Frame: Up to Week 80
Up to Week 80
Plasma Concentrations of KAI-9531
Time Frame: Up to Week 76
Up to Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time Frame: Baseline, Week 76
Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in BMI
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Time Frame: Baseline, Week 76
Baseline, Week 76
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kailera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K9531-3103
  • 2025-523486-17-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings