CompletedPhase 1ACTRN12625000782437

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study to investigate safety, tolerability and pharmacokinetics following multiple dose administration of KAI-7535 in participants with obesity and overweight

Sponsor

Kailera Therapeutics, Inc. 890 Winter Street, Suite 220 Waltham MA 0245, United States

Enrollment

46 participants

Start Date

Sep 5, 2025

Study Type

Interventional

Conditions

Obesity Overweight Metabolic Diseases

Summary

This is a randomised, double-blind, placebo-controlled, parallel group study evaluating the safety, tolerability and PK of multiple doses of KAI-7531 in a non-Asian (Cohort 1) and Asian (Cohort 2) participants. The study will also evaluate the effect of food on safety, tolerability, and PK. Who is it for? You may be eligible for this study if you are aged 18 to 55 years with body mass index of 25.0 to 40.0 kg/m2 (inclusive), medically healthy and without clinically significant (CS) abnormalities. Study details All participants who choose to enrol in this study will be assigned by chance to receive multiple doses of KAI-7531 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc). and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose tolerated of KAI-7531 that can be administered safely without causing severe reactions. KAI-7531 is intended to be used for the treatment of metabolic diseases such as type 2 diabetes mellitus and obesity or overweight with comorbidities. The data collected will also support dose administration for future clinical studies.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria7

Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
Adult males and females, 18 to 55 years of age (inclusive) at screening.
Cohort 1 ONLY: Are of non-Asian descent and do not identify as being of East Asian origin.
Cohort 2 ONLY: Are of Asian descent, identify as being of East Asian origin, and have both parents and both sets of grandparents born in East Asia.
BMI greater than or equal to 25.0 and less than or equal to 40.0 kg/m2, with a body weight less than or equal to 120 kg at screening and Day -1.
Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Willing and able to comply with modified food and eating habits that reduce nausea and vomiting for this class of drug.

Exclusion Criteria10

Known hypersensitivity to study drug or any study drug ingredients.
History of anaphylaxis or other significant allergy that, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study (including, but not limited to, those with a with known allergy to GLP-1 and/or gastric inhibitory polypeptide [GIP] receptor agonists and their excipients).
History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
History of surgery or hospitalisation prior to screening (at least 1 month prior for minor surgery and at least 3 months prior for all other surgery), surgery planned during the study, or history of bariatric surgery (at any time).
Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma). Any personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 is exclusionary.
Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrhythmia.
Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption (excluding appendectomy and cholecystectomy), distribution, metabolism, or excretion of drugs.
A history of or positive test results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) confirmation if positive.
Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening. In case of participation in another clinical study involving GLP-1, GLP-1/GIP, or GLP-1/GIP/glucagon receptor (GCGR) investigational drugs, the volunteer must have taken the last dose from that clinical study at least 3 months prior to the first dose of study treatment.

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Interventions

This is a randomised, double-blind, placebo-controlled, parallel group study evaluating the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of KAI-7535 tablets or matching placebo tablets. The purpose of the study is to examine the safety, tolerability and PK of KAI-7535 in non-Asian and Asian populations. The study will also evaluate the effect of food on the safety, tolerability, and PK of KAI-7535. Up to 46 participants are planned to be enrolled across 2 cohorts. Cohort 1 will enroll up to 36 participants of non-Asian descent. Participants enrolled into Cohort 1 will be randomised into one of three KAI-7535 oral tablet treatment sequences or matching placebo. The three KAI-7535 treatment sequences will consist of: 1) 30 mg once daily fasted administration for 14 days followed by 60 mg once daily fasted administration for 14 days 2) 30 mg once daily fed administration for 14 days followed by 60 mg once daily fed administration for 14 days 3) 60 mg once daily fed administration for 14 days followed by 120 mg once daily fed administration for 14 days. Cohort 2 will enroll up to 10 participants of Asian descent with participants randomised to receive either KAI-7535 oral tablets or matching placebo 30 mg once daily fasted administration for 14 days followed by 60 mg once daily fasted administration for 14 days. From Day 1 through Day 28, participants randomised to fed treatment groups, following a minimum 8 hour overnight fast, will be administered study drug 30 minutes after the start of a low-fat meal. Participants randomized to a fasted treatment group will be administered study drug following a minimum 8 hour overnight fast. Study drug will be administered at the study site by trained study site personnel to ensure compliance.