DelfaGLP-1 Atlas

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Enrolling by invitationPhase 2

Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Lead sponsor

Kailera

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

35

Recruiting sites

—

Enrollment

250

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥35

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 IDNCT07458269
Org study IDK9531-2110

Timeline

Milestones

Study start2026-03-04actual
Study first posted2026-03-09actual
Last update posted2026-05-29actual
Primary completion2027-05estimated (month precision)
Study completion2027-06estimated (month precision)

Assets

Investigational agents

HRS9531

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Key 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.

Key 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.

Endpoints (17)

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

Cardiometabolic biomarkers
6
Weight & body composition
5
Safety / tolerability / PK
4
Glycemic / diabetes
2

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 48

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 48

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 48

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Percent Change From Baseline in Fasting Triglycerides

Time frame:Baseline, Week 48

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 48

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 48

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Total Cholesterol

Time frame:Baseline, Week 48

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 48

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

VLDL, change

percent 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 52

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Anti-drug Antibodies (ADAs)

Time frame:Day 1 up to Week 52

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Neutralizing Antibodies (NAbs)

Time frame:Day 1 up to Week 52

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Plasma Concentrations of KAI-9531

Time frame:Day 1 up to Week 52

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.