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Recruiting NCT07497880

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Phase II Interventional Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KAI-7535, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Overview

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.

Interventions

  • Drug KAI-7535
    Oral tablets
  • Drug Placebo
    Oral tablets

Primary outcome measures

  • Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus [Time frame: Baseline, Week 44]
Secondary outcome measures (7)
  • Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus [Time frame: Baseline, Week 44]
  • Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus [Time frame: Baseline, Week 44]
  • Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus [Time frame: Week 44]
  • Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Time frame: Baseline, Week 44]
  • Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Time frame: Baseline, Week 44]
  • Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Time frame: Baseline, Week 44]
  • Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus [Time frame: Week 44]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 31 centers
  • Kailera Clinical Site — Chandler
  • Kailera Clinical Site — Phoenix
  • Kailera Clinical Site — Irvine
  • Kailera Clinical Site — Lincoln
  • Kailera Clinical Site — Northridge
  • Kailera Clinical Site — Hamden
  • Kailera Clinical Site — Jacksonville
  • Kailera Clinical Site — Jupiter
  • … and 23 more centers
Australia · 5 centers
  • Kailera Clinical Site — Dee Why
  • Kailera Clinical Site — Miranda
  • Kailera Clinical Site — Wollongong
  • Kailera Clinical Site — Norwood
  • Kailera Clinical Site — Altona N.

Identifiers

NCT: NCT07497880 · K7535-2101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗