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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KAI-9531: Dose 1 		Participants will receive Dose 1 of KAI-9531 once weekly.
  • Drug: KAI-9531
    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
Placebo Comparator
Placebo 		Participants will receive placebo matched to KAI-9531 once weekly.
  • Drug: Placebo
    SC Injection

Recruiting Locations

Kailera Clinical Site
Anniston 4830198, Alabama 4829764 36207

Kailera Clinical Site
Cullman 4057835, Alabama 4829764 35055

Kailera Clinical Site
Sun City 5316201, Arizona 5551752 85351

Kailera Clinical Site
Aurora 5412347, Colorado 5417618 80012

Kailera Clinical Site
Bridgeport 5282804, Connecticut 4831725 06606

Kailera Clinical Site
Jupiter 4160610, Florida 4155751 33458

Kailera Clinical Site
Lilburn 4205724, Georgia 4197000 30047

Kailera Clinical Site
Springfield 4250542, Illinois 4896861 62072

Kailera Clinical Site
Columbia 4352053, Maryland 4361885 21045

Kailera Clinical Site
Las Vegas 5506956, Nevada 5509151 89119

Kailera Clinical Site
Rochester 5134086, New York 5128638 14609

Kailera Clinical Site
Morehead City 4480153, North Carolina 4482348 28557

Kailera Clinical Site
Chickasha 4533029, Oklahoma 4544379 73018

Kailera Clinical Site
Mauldin 4586523, South Carolina 4597040 29662

Kailera Clinical Site
Chattanooga 4612862, Tennessee 4662168 37405

Kailera Clinical Site
Amarillo 5516233, Texas 4736286 79124

Kailera Clinical Site
DeSoto 4685524, Texas 4736286 75115

Kailera Clinical Site
Tomball 4737094, Texas 4736286 77375

Kailera Clinical Site
Salt Lake City 5780993, Utah 5549030 84124

Kailera Clinical Site
Danville 4755280, Virginia 6254928 24541

More Details

Status
Recruiting
Sponsor
Kailera

Study Contact

Kailera Therapeutics, Inc.
781-317-0291
info-clinicalstudies@kailera.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.