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Active, not recruitingNCT07458269Updated Jul 15, 2026

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

A Phase 2 interventional study of Ribupatide and Placebo in Obesity, sponsored by Kailera. Active, not recruiting at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Kailera · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Ribupatide
  • KAI-9531
  • Glucagon-like peptide-1
  • GLP-1
  • Glucose-dependent Insulinotropic Peptide
  • GIP
  • Obesity Without Diabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 264 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Kailera is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
264 participants (actual)

Study arms

  • Experimental
    Ribupatide: Dose 1

    Participants will receive Dose 1 of ribupatide once weekly.

    Drug: Ribupatide

  • Experimental
    Ribupatide: Dose 2

    Participants will receive Dose 2 of ribupatide once weekly.

    Drug: Ribupatide

  • Experimental
    Ribupatide: Dose 3

    Participants will receive Dose 3 of ribupatide once weekly.

    Drug: Ribupatide

  • Experimental
    Ribupatide: Dose 4

    Participants will receive Dose 4 of ribupatide once weekly.

    Drug: Ribupatide

  • Placebo comparator
    Placebo

    Participants will receive placebo matched to ribupatide once weekly.

    Drug: Placebo

Interventions

  • DrugRibupatide

    SC Injection

    Also known as: KAI-9531

  • DrugPlacebo

    SC Injection

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 48

    Time frame: Baseline, Week 48

Secondary outcomes

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

    Time frame: Baseline, Week 48

  2. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 48

  3. Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 48

  4. Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 48

  5. Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 48

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

    Time frame: Baseline, Week 48

  7. Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Time frame: Baseline, Week 48

  8. Percent Change From Baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 48

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

    Time frame: Baseline, Week 48

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

    Time frame: Baseline, Week 48

  11. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, Week 48

  12. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, Week 48

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

    Time frame: Day 1 up to Week 52

  14. Number of Participants With Anti-drug Antibodies (ADAs)

    Time frame: Day 1 up to Week 52

  15. Number of Participants With Neutralizing Antibodies (NAbs)

    Time frame: Day 1 up to Week 52

  16. Plasma Concentrations of Ribupatide

    Time frame: Day 1 up to Week 52

07

Study locations

35 sites
  • Kailera Clinical Site
    Mesa, Arizona 85213, United States
  • Kailera Clinical Site
    Sun City West, Arizona 85375, United States
  • Kailera Clinical Site
    Irvine, California 92614, United States
  • Kailera Clinical Site
    Lake Forest, California 92630, United States
  • Kailera Clinical Site
    Lomita, California 90717, United States
  • Kailera Clinical Site
    Long Beach, California 90815, United States
  • Kailera Clinical Site
    Montclair, California 91763, United States
  • Kailera Clinical Site
    Rolling Hills Estates, California 90274, United States
  • Kailera Clinical Site
    San Diego, California 92103, United States
  • Kailera Clinical Site
    Santa Ana, California 92704, United States
  • Kailera Clinical Site
    Van Nuys, California 91405, United States
  • Kailera Clinical Site
    DeLand, Florida 32720, United States
  • Kailera Clinical Site
    Orlando, Florida 32801, United States
  • Kailera Clinical Site
    Orlando, Florida 32803, United States
  • Kailera Clinical Site
    The Villages, Florida 32162, United States
  • Kailera Clinical Site
    Decatur, Georgia 30030, United States
  • Kailera Clinical Site
    Woodstock, Georgia 30189, United States
  • Kailera Clinical Site
    Morton, Illinois 61550, United States
  • Kailera Clinical Site
    Indianapolis, Indiana 46254, United States
  • Kailera Clinical Site
    Louisville, Kentucky 40213, United States
  • Kailera Clinical Site
    Rockville, Maryland 20852, United States
  • Kailera Clinical Site
    St Louis, Missouri 63141, United States
  • Kailera Clinical Site
    Lincoln, Nebraska 68516, United States
  • Kailera Clinical Site
    Omaha, Nebraska 68144, United States
  • Kailera Clinical Site
    East Syracuse, New York 13057, United States
  • Kailera Clinical Site
    Greensboro, North Carolina 27405, United States
  • Kailera Clinical Site
    Monroe, North Carolina 28112, United States
  • Kailera Clinical Site
    Raleigh, North Carolina 27612, United States
  • Kailera Clinical Site
    Greenville, South Carolina 29607, United States
  • Kailera Clinical Site
    Myrtle Beach, South Carolina 29572, United States
  • Kailera Clinical Site
    Knoxville, Tennessee 37909, United States
  • Kailera Clinical Site
    Memphis, Tennessee 38119, United States
  • Kailera Clinical Site
    Garland, Texas 75043, United States
  • Kailera Clinical Site
    San Antonio, Texas 78215, United States
  • Kailera Clinical Site
    Winchester, Virginia 22601, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07458269
Lead sponsor
Kailera
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Mar 4, 2026
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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