GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

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 and Diabetes

Lead sponsor

Kailera

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

1,700

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07284901

Org study IDK9531-3104

Secondary ID2025-523510-87-00

Timeline

Milestones

Study first posted2025-12-16actual

Study start2026-01-12actual

Last update posted2026-05-28actual

Primary completion2028-03-27estimated

Study completion2028-04-24estimated

Assets

Investigational agents

HRS9531

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key 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.

Key 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.

Endpoints (35)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

8 endpoints

Primary/protocol endpoint

Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame:Baseline, Week 76

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Doses 1 and 2 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame:Baseline, Week

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 76

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 76

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 76

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥30% Reduction in Body Weight

Time frame:Baseline, Week 76

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in BMI

Time frame:Baseline, Week 76

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76

Time frame:Baseline, Week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Doses 1 and 2 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76

Time frame:Baseline, Week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants with HbA1c <7% and ≤6.5%

Time frame:Baseline, Week 760

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, Week 76

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants with HbA1c <5.7%

Time frame:Baseline, Week 76

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 76

percent change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 76

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Triglycerides

Time frame:Baseline, Week 76

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol

Time frame:Baseline, Week 76

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Non-HDL-cholesterol

Time frame:Baseline, Week 76

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 76

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Total Cholesterol

Time frame:Baseline, Week 76

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol

Time frame:Baseline, Week 76

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol

Time frame:Baseline, Week 76

VLDL, change

percent change from baseline, improvement

Patient-reported / QoL

9 endpoints

Secondary/protocol endpoint

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Positive Mood Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Craving for Sweets Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Craving for Savory Food Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Hunger Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Satiety Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CoEQ Combined Score

Time frame:Baseline, Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Food Noise Questionnaire (FNQ) Score

Time frame:Baseline, Week 76

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 up to Week 80

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Anti-drug Antibodies (ADAs)

Time frame:Up to Week 80

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Neutralizing Antibodies (Nabs)

Time frame:Up to Week 80

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Plasma Concentrations of KAI-9531

Time frame:Up to Week 76

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.