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Purpose

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: - Percent change in body weight - Change in hemoglobin A1c (HbA1c)

Conditions

Eligibility

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

Inclusion Criteria

  • Diagnosis of type 2 diabetes mellitus (T2DM). - Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors. - BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. - History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. - History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. - 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 (GI) motility if taken for >30 days continually within 3 months prior to Screening. - 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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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
Cullman, Alabama 35055

Kailera Clinical Site
Phoenix, Arizona 85012

Kailera Clinical Site
Sun City, Arizona 85351

Kailera Clinical Site
Little Rock, Arkansas 72205

Kailera Clinical Site
Escondido, California 92025

Kailera Clinical Site
Northridge, California 91325

Kailera Clinical Site
Oceanside, California 92058

Kailera Clinical Site
Toluca Lake, California 91602

Kailera Clinical Site
Stamford, Connecticut 06905

Kailera Clinical Site
Jupiter, Florida 33458

Kailera Clinical Site
Orange City, Florida 32763

Kailera Clinical Site
Lilburn, Georgia 30047

Kailera Clinical Site
Skokie, Illinois 60077

Kailera Clinical Site
Newton, Kansas 67114

Kailera Clinical Site
Shreveport, Louisiana 71105

Kailera Clinical Site
Columbia, Maryland 21045

Kailera Clinical Site
Farmington Hills, Michigan 48334

Kailera Clinical Site
Missoula, Montana 59804

Kailera Clinical Site
Lincoln, Nebraska 68516

Kailera Clinical Site
Las Vegas, Nevada 89148

Kailera Clinical Site
Albany, New York 12203

Kailera Clinical Site
Laurelton, New York 11413

Kailera Clinical Site
Greensboro, North Carolina 27405

Kailera Clinical Site
Morehead City, North Carolina 28557

Kailera Clinical Site
Chickasha, Oklahoma 73018

Kailera Clinical Site
Spartanburg, South Carolina 29303

Kailera Clinical Site
Amarillo, Texas 79124

Kailera Clinical Site
Brownsville, Texas 78526

Kailera Clinical Site
DeSoto, Texas 75115

Kailera Clinical Site
Tomball, Texas 77375

Kailera Clinical Site
Salt Lake City, Utah 84117

Kailera Clinical Site
Manassas, Virginia 20110

Kailera Clinical Site
Richmond, Virginia 23236

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.