DelfaGLP-1 Atlas

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RecruitingPhase 3

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have 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 With Weight-Related Comorbidities Who Do Not Have Diabetes

Lead sponsor

Kailera

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

36

Recruiting sites

36

Enrollment

1,800

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % 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 IDNCT07284875
Org study IDK9531-3103
Secondary ID2025-523486-17-00

Timeline

Milestones

Study first posted2025-12-16actual
Study start2025-12-18actual
Last update posted2026-05-08actual
Primary completion2028-02-28estimated
Study completion2028-03-27estimated

Assets

Investigational agents

HRS9531

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (31)

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
9
Weight & body composition
8
Cardiometabolic biomarkers
8
Safety / tolerability / PK
4
Glycemic / diabetes
2

Weight & body composition

8 endpoints
Primary/protocol endpoint

Dose 3 and 4 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

Dose 1 and 2 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

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/low confidence

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

2 endpoints
Secondary/protocol endpoint

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 76

percent change from baseline, improvement

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

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 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 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.