NCT07497880

Brief Summary

The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2 obesity

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

March 23, 2026

Last Update Submit

May 12, 2026

Conditions

ObesityOverweight

Keywords

ObesityOverweightGlucagon-like peptide-1GLP-1KAI-7535DiabetesOral

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus

    Baseline, Week 44

Secondary Outcomes (7)

  • Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus

    Baseline, Week 44

  • Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus

    Baseline, Week 44

  • Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus

    Week 44

  • Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus

    Baseline, Week 44

  • Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus

    Baseline, Week 44

  • +2 more secondary outcomes

Study Arms (5)

KAI-7535: Dose Schedule 1

EXPERIMENTAL

Participants will receive KAI-7535 once daily.

Drug: KAI-7535

KAI-7535: Dose Schedule 2

EXPERIMENTAL

Participants will receive KAI-7535 once daily.

Drug: KAI-7535

KAI-7535: Dose Schedule 3

EXPERIMENTAL

Participants will receive KAI-7535 once daily.

Drug: KAI-7535

KAI-7535: Dose Schedule 4

EXPERIMENTAL

Participants will receive KAI-7535 once daily.

Drug: KAI-7535

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to KAI-7535 once daily.

Drug: Placebo

Interventions

KAI-7535DRUG

Oral tablets

KAI-7535: Dose Schedule 1KAI-7535: Dose Schedule 2KAI-7535: Dose Schedule 3KAI-7535: Dose Schedule 4
PlaceboDRUG

Oral tablets

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
  • Hypertension
  • Dyslipidemia
  • Obstructive sleep apnea
  • Cardiovascular disease
  • For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
  • Diagnosis of type 2 diabetes mellitus
  • On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening

You may not qualify if:

  • For participants without diabetes:
  • Laboratory evidence of diabetes
  • Taking a concomitant medication for the indication of glycemic control
  • For participants living with type 2 diabetes mellitus only:
  • History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
  • History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
  • History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
  • Started medications that may cause significant weight change within 3 months prior to screening, including 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 carcinoma
  • 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 or other severe psychiatric disorder
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kailera Clinical Site

Chandler, Arizona, 85225, United States

RECRUITING

Kailera Clinical Site

Irvine, California, 92614, United States

RECRUITING

Kailera Clinical Site

Lincoln, California, 95648, United States

RECRUITING

Kailera Clinical Site

Northridge, California, 91325, United States

RECRUITING

Kailera Clinical Site

Hamden, Connecticut, 06517, United States

RECRUITING

Kailera Clinical Site

Jupiter, Florida, 33458, United States

RECRUITING

Kailera Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Kailera Clinical Site

South Bend, Indiana, 46617, United States

RECRUITING

Kailera Clinical Site

Kenner, Louisiana, 70065, United States

RECRUITING

Kailera Clinical Site

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

1-781-317-0291info-clinicalstudies@kailera.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

July 7, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(10)