NCT07284875

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for phase_3 obesity

Timeline
23mo left

Started Dec 2025

Typical duration for phase_3 obesity

Geographic Reach
3 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Dec 2025Mar 2028

First Submitted

Initial submission to the registry

December 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 18, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

December 9, 2025

Last Update Submit

April 29, 2026

Conditions

ObesityOverweight

Keywords

OverweightObesityKAI-9531Glucagon-like Peptide-1GLP-1Glucose-dependent Insulinotropic PeptideGIP

Outcome Measures

Primary Outcomes (1)

  • Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Baseline, Week 76

Secondary Outcomes (30)

  • Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Baseline, Week 76

  • Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Baseline, Week 76

  • Change From Baseline in Waist Circumference

    Baseline, Week 76

  • Change From Baseline in Absolute Body Weight

    Baseline, Week 76

  • Change From Baseline in Systolic Blood Pressure (SBP)

    Baseline, Week 76

  • +25 more secondary outcomes

Study Arms (5)

KAI-9531: Dose 1

EXPERIMENTAL

Participants will receive Dose 1 of KAI-9531 once weekly.

Drug: KAI-9531

KAI-9531: Dose 2

EXPERIMENTAL

Participants will receive Dose 2 of KAI-9531 once weekly.

Drug: KAI-9531

KAI-9531: Dose 3

EXPERIMENTAL

Participants will receive Dose 3 of KAI-9531 once weekly.

Drug: KAI-9531

KAI-9531: Dose 4

EXPERIMENTAL

Participants will receive Dose 4 of KAI-9531 once weekly.

Drug: KAI-9531

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to KAI-9531 once weekly.

Drug: Placebo

Interventions

KAI-9531DRUG

SC Injection

KAI-9531: Dose 1KAI-9531: Dose 2KAI-9531: Dose 3KAI-9531: Dose 4
PlaceboDRUG

SC Injection

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
  • hypertension,
  • dyslipidemia,
  • obstructive sleep apnea, or
  • cardiovascular (CV) disease.
  • History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Kailera Clinical Site

Anniston, Alabama, 36207, United States

RECRUITING

Kailera Clinical Site

Cullman, Alabama, 35055, United States

RECRUITING

Kailera Clinical Site

Sun City, Arizona, 85351, United States

RECRUITING

Kailera Clinical Site

Escondido, California, 92025, United States

RECRUITING

Kailera Clinical Site

Toluca Lake, California, 91602, United States

RECRUITING

Kailera Clinical Site

Aurora, Colorado, 80012, United States

RECRUITING

Kailera Clinical Site

Bridgeport, Connecticut, 06606, United States

RECRUITING

Kailera Clinical Site

Jupiter, Florida, 33458, United States

RECRUITING

Kailera Clinical Site

Lilburn, Georgia, 30047, United States

RECRUITING

Kailera Clinical Site

Springfield, Illinois, 62072, United States

RECRUITING

Kailera Clinical Site

Columbia, Maryland, 21045, United States

RECRUITING

Kailera Clinical Site

Las Vegas, Nevada, 89119, United States

RECRUITING

Kailera Clinical Site

Rochester, New York, 14609, United States

RECRUITING

Kailera Clinical Site

Morehead City, North Carolina, 28557, United States

RECRUITING

Kailera Clinical Site

Chickasha, Oklahoma, 73018, United States

RECRUITING

Kailera Clinical Site

Mauldin, South Carolina, 29662, United States

RECRUITING

Kailera Clinical Site

Chattanooga, Tennessee, 37405, United States

RECRUITING

Kailera Clinical Site

Amarillo, Texas, 79124, United States

RECRUITING

Kailera Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Kailera Clinical Site

Tomball, Texas, 77375, United States

RECRUITING

Kailera Clinical Site

Salt Lake City, Utah, 84124, United States

RECRUITING

Kailera Clinical Site

Danville, Virginia, 24541, United States

RECRUITING

Kailera Clinical Site

Silverdale, Auckland, 0932, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2100, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2228, Australia

RECRUITING

Kailera Clinical Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

Kailera Clinical Site

Sippy Downs, Queensland, 4556, Australia

RECRUITING

Kailera Clinical Site

Norwood, South Australia, 5067, Australia

RECRUITING

Kailera Clinical Site

Melbourne, Victoria, 3025, Australia

RECRUITING

Kailera Clinical Site

Grafton, Auckland, 1010, New Zealand

RECRUITING

Kailera Clinical Site

Hamilton, Waikato Region, 3200, New Zealand

RECRUITING

Kailera Clinical Site

Auckland, 0610, New Zealand

RECRUITING

Kailera Clinical Site

Nelson, 7011, New Zealand

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

781-317-0291info-clinicalstudies@kailera.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 16, 2025

Study Start

December 18, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

March 27, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NZ(4)AU(7)US(22)