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Trial registered on ANZCTR


Registration number
ACTRN12625000782437p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2025
Date registered
24/07/2025
Date last updated
24/07/2025
Date data sharing statement initially provided
24/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 314390 0
K7535-1708
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Diseases 337720 0
Obesity 338307 0
Overweight 338308 0
Condition category
Condition code
Metabolic and Endocrine 333772 333772 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331001 0
Treatment: Drugs
Comparator / control treatment
Placebo tablet identical in appearance to investigational product containing anhydrous sodium carbonate, mannitol, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, and film coating premix (enteric-coated) as excipients.
Control group
Placebo

Outcomes
Primary outcome [1] 341357 0
Composite Outcome: To evaluate the safety and tolerability of multiple-dose administration of KAI-7535 in participants with obesity and overweight
Timepoint [1] 341357 0
Adverse events will be assessed by clinical examination and participant self-report and reviewed at Screening, daily from Day -1 to Day 30 and Day 35 End of Study/Early Termination Visit (EOT/ETV). Vital signs assessments will include systolic and diastolic blood pressure assessed using sphygmomanometer, pulse rate and respiratory rate assessed using pulse oximeter and body temperature (only tympanic temperature accepted) assessed by thermometer, will be assessed from Screening, Day -1, pre-dose Days 1, 3, 7, 14, 15, 17, 21, 28, 29 and Day 30 and Day 35 End of Study/Early Termination Visit (EOT/ETV). Triplicate ECG's will be conducted at Screening, Day -1, pre-dose on Days 1, 14, 15, 28, and Day 29 and at Day 35 End of Study/Early Termination Visit (EOT/ETV). Clinical laboratory and blood and urine samples will be collected from Screening, Day -1, pre-dose on Days 3, 7, 14, 17, 21, and Day 29 and in the event of Early Termination.
Secondary outcome [1] 447271 0
To evaluate the pharmacokinetics (PK) of KAI-7535 in plasma following multiple-dose administration of KAI-7535 in participants with obesity and overweight
Timepoint [1] 447271 0
Blood plasma samples will be assessed pre-dose on Day 1, then 1, 2, 3, 4, 6, 8, 10 and 12 hrs post-dose, pre-dose Day 2, pre-dose on Day 14, then 1, 2, 3, 4, 6, 8, 10 and 12 hrs post-dose, pre-dose Day 15, pre-dose on Day 28, then 1, 2, 3, 4, 6, 8, 10, 12 and 16 hrs post-dose, Day 29 at 24 hrs post-dose and Day 30 at 48 hrs post-dose.

Eligibility
Key inclusion criteria
1. 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.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. Cohort 1 ONLY: Are of non-Asian descent and do not identify as being of East Asian origin.
4. 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.
5. 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.
6. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
7. Willing and able to comply with modified food and eating habits that reduce nausea and vomiting for this class of drug.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity to study drug or any study drug ingredients.
2. 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).
3. 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.
4. 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).
5. 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.
6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
7. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrhythmia.
8. 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.
9. 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.
10. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the study eligibility criteria for Cohort 1 will be randomised and assigned a randomisation number pre-dose on Day 1, which corresponds to 1 of the 3 treatment sequences and treatment of KAI-7535 or placebo in a 5:1 ratio within each treatment sequence in accordance with the randomisation schedule.
Participants who meet the study eligibility criteria for Cohort 2 will be randomised and assigned a randomisation number pre-dose on Day 1, which corresponds to treatment of KAI-7535 or placebo in a 4:1 ratio in accordance with the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by an independent unblinded statistician, using a computer-generated allocation code.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 27898 0
Nucleus Network - Melbourne
Recruitment hospital [2] 27970 0
Nucleus Network Brisbane Clinic - Herston
Recruitment postcode(s) [1] 44094 0
3004 - Melbourne
Recruitment postcode(s) [2] 44163 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 318909 0
Commercial sector/Industry
Name [1] 318909 0
Kailera Therapeutics, Inc. 890 Winter Street, Suite 220 Waltham MA 0245, United States
Country [1] 318909 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kailera Therapeutics, Inc. 890 Winter Street, Suite 220 Waltham MA 0245, United States
Address
Country
United States of America
Secondary sponsor category [1] 321371 0
Commercial sector/Industry
Name [1] 321371 0
Avance Clinical Pty Ltd
Address [1] 321371 0
Country [1] 321371 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317524 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317524 0
Ethics committee country [1] 317524 0
Australia
Date submitted for ethics approval [1] 317524 0
25/06/2025
Approval date [1] 317524 0
Ethics approval number [1] 317524 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141322 0
Dr Aarthy Joseph
Address 141322 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Road, Melbourne, VIC, 3004
Country 141322 0
Australia
Phone 141322 0
+61 0385 939 801
Fax 141322 0
Email 141322 0
[email protected]
Contact person for public queries
Name 141323 0
Dr Aarthy Joseph
Address 141323 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Road, Melbourne, VIC, 3004
Country 141323 0
Australia
Phone 141323 0
+61 1800 243 733
Fax 141323 0
Email 141323 0
[email protected]
Contact person for scientific queries
Name 141324 0
Aarthy Joseph
Address 141324 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Road, Melbourne, VIC, 3004
Country 141324 0
Australia
Phone 141324 0
+61 0385 939 801
Fax 141324 0
Email 141324 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.