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Purpose

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

Condition

Eligibility

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

Inclusion Criteria

  • BMI ≥35 kilograms per meter squared (kg/m^2). - 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, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. - 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 within 2 years prior to Screening. - Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Design

Phase
Phase 2
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
Mesa, Arizona 85213

Kailera Clinical Site
Sun City West, Arizona 85375

Kailera Clinical Site
Lake Forest, California 92630

Kailera Clinical Site
Lomita, California 90717

Kailera Clinical Site
Long Beach, California 90815

Kailera Clinical Site
Montclair, California 91763

Kailera Clinical Site
Rolling Hills Estates, California 90274

Kailera Clinical Site
San Diego, California 92103

Kailera Clinical Site
Santa Ana, California 92704

Kailera Clinical Site
Van Nuys, California 91405

Kailera Clinical Site
DeLand, Florida 32720

Kailera Clinical Site
Orlando, Florida 32801

Kailera Clinical Site
Orlando, Florida 32803

Kailera Clinical Site
The Villages, Florida 32162

Kailera Clinical Site
Decatur, Georgia 30030

Kailera Clinical Site
Woodstock, Georgia 30189

Kailera Clinical Site
Morton, Illinois 61550

Kailera Clinical Site
Indianapolis, Indiana 46254

Kailera Clinical Site
Louisville, Kentucky 40213

Kailera Clinical Site
Rockville, Maryland 20852

Kailera Clinical Site
St Louis, Missouri 63141

Kailera Clinical Site
Lincoln, Nebraska 68516

Kailera Clinical Site
Omaha, Nebraska 68144

Kailera Clinical Site
East Syracuse, New York 13057

Kailera Clinical Site
Greensboro, North Carolina 27405

Kailera Clinical Site
Monroe, North Carolina 28112

Kailera Clinical Site
Raleigh, North Carolina 27612

Kailera Clinical Site
Greenville, South Carolina 29607

Kailera Clinical Site
Myrtle Beach, South Carolina 29572

Kailera Clinical Site
Knoxville, Tennessee 37909

Kailera Clinical Site
Memphis, Tennessee 38119

Kailera Clinical Site
San Antonio, Texas 78215

Kailera Clinical Site
Winchester, Virginia 22601

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.