TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-... (as listed in product record) for Obesity

Inclusion criteria

• {"criterion_text":"-BMI ≥35 kg/m"}
• {"criterion_text":"-History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months."}

Exclusion criteria

• {"criterion_text":"-Current diagnosis or history of diabetes mellitus"}
• {"criterion_text":"-Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening."}
• {"criterion_text":"-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."}
• {"criterion_text":"-Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening."}
• {"criterion_text":"-Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer."}
• {"criterion_text":"-Uncontrolled hypertension or unstable cardiovascular disease"}
• {"criterion_text":"-History of chronic or acute pancreatitis"}
• {"criterion_text":"-Known clinically significant gastric-emptying abnormality (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility."}
• {"criterion_text":"-History of suicide attempt."}
• {"criterion_text":"-History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder"}

Primary endpoints

• {"endpoint_text":"-Percent change in body weight (kg) from baseline at Week 76","definition_or_measurement_approach":"Measured as percent change in body weight (kg) from baseline at Week 76."}

Secondary endpoints

• {"endpoint_text":"-controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg)","definition_or_measurement_approach":"From baseline at Week 76: percentage of participants achieving predefined percent reductions in body weight; change in waist circumference (cm); change in absolute body weight (kg)."}
• {"endpoint_text":"-controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score","definition_or_measurement_approach":"From baseline at Week 76: percent of participants with ≥5% weight reduction; change in systolic blood pressure (SBP); changes in specified lipid parameters (mg/dL); change in IWQOL-Lite-CT physical function composite score."}
• {"endpoint_text":"-not controlled for Type I error from baseline at Week 76: • Percentage of participants with ≥30% reduction in body weight (kg) • Change in BMI (kg/m2) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score","definition_or_measurement_approach":"From baseline at Week 76: percent with ≥30% weight reduction; change in BMI; changes in patient-reported outcome scores (CoEQ domains, FNQ)."}
• {"endpoint_text":"-not controlled for Type I error Number ofTEAEs","definition_or_measurement_approach":"Number of treatment-emergent adverse events (TEAEs) recorded during treatment period."}
• {"endpoint_text":"-not controlled for Type I error ADA NAb","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)."}
• {"endpoint_text":"-not controlled for Type I error Concentrations of KAI-9531","definition_or_measurement_approach":"Measurement of KAI-9531 plasma concentrations (PK assessments)."}

Methods

• Country-specific recruitment arrangements documents and materials (K1 and K2 documents): Participant Brochure, Patient Flyer, Participant Poster, Physician Referral Letter, Doctor-to-Participant Letter, Pre-enrolment Information Card, HCP Fact Sheet, Study Information Slides (documents listed for Bulgaria and Poland).
• Subject information sheets and informed consent forms provided (SIS and Main ICF country-specific versions for Bulgaria and Poland).
• Recruitment materials include physician referral and doctor-to-participant letters indicating clinician referral channels.
• Pre-enrolment information card and participant brochures indicate direct-to-patient printed recruitment materials.

Bulgaria

Earliest CTIS Part Ii Submission Date

01-04-2026

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

33

Number Of Sites

9

Number Of Participants

142

Poland

Earliest CTIS Part Ii Submission Date

01-04-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

28

Number Of Sites

8

Number Of Participants

126

Primary sponsor

Full Name

Kailera Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Clinical operations and multiple vendor services including Remote Dietitian Services, Provision of online subject portal, Cardiac services

Name

Icon Clinical Research Limited

Responsibilities

Clinical research services (sponsor duties code 4)

Third parties

• {"country":"United States","full_name":"Llx Solutions LLC","duties_or_roles":"Sponsor duties codes: 10","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Duties codes: 1, 12, 15, 2, 5, 8. Specified services: Remote Dietitian Services, Provision of online subject portal, Cardiac services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Concierge Service – Patient transportation - Reimbursement of patient expense (sponsor duties code 15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Lost to follow-up patient search (sponsor duties code 15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"Sample management / laboratory services (sponsor duties codes 4)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Samples long term storage (sponsor duties code 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"Safety adjudication (sponsor duties code 15)","organisation_type":"Educational Institution"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sample management / laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eClinical platform / data services (sponsor duties code 7)","organisation_type":"Non-Pharmaceutical company"}