Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:31 PM
Study NCT ID:
NCT07458269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at Week 48', 'timeFrame': 'Baseline, Week 48'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in Absolute Body Weight', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Non-HDL-cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Total Cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Percent Change From Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in Fasting Blood Glucose', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to Week 52'}, {'measure': 'Number of Participants With Anti-drug Antibodies (ADAs)', 'timeFrame': 'Day 1 up to Week 52'}, {'measure': 'Number of Participants With Neutralizing Antibodies (NAbs)', 'timeFrame': 'Day 1 up to Week 52'}, {'measure': 'Plasma Concentrations of KAI-9531', 'timeFrame': 'Day 1 up to Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'KAI-9531', 'Glucagon-like peptide-1', 'GLP-1', 'Glucose-dependent Insulinotropic Peptide', 'GIP', 'Obesity Without Diabetes'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the effects of KAI-9531 administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* BMI ≥35 kilograms per meter squared (kg/m\\^2).\n* History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.\n\nKey Exclusion Criteria:\n\n* Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.\n* 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.\n* Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.\n* Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.\n* Uncontrolled hypertension or unstable cardiovascular disease.\n* History of chronic or acute pancreatitis.\n* Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.\n* History of suicide attempt.\n* History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.\n* Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening.\n\nNote: Additional inclusion/exclusion criteria may apply, per protocol.'}, 'identificationModule': {'nctId': 'NCT07458269', 'briefTitle': 'Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kailera'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes', 'orgStudyIdInfo': {'id': 'K9531-2110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KAI-9531: Dose 1', 'description': 'Participants will receive Dose 1 of KAI-9531 once weekly.', 'interventionNames': ['Drug: KAI-9531']}, {'type': 'EXPERIMENTAL', 'label': 'KAI-9531: Dose 2', 'description': 'Participants will receive Dose 2 of KAI-9531 once weekly.', 'interventionNames': ['Drug: KAI-9531']}, {'type': 'EXPERIMENTAL', 'label': 'KAI-9531: Dose 3', 'description': 'Participants will receive Dose 3 of KAI-9531 once weekly.', 'interventionNames': ['Drug: KAI-9531']}, {'type': 'EXPERIMENTAL', 'label': 'KAI-9531: Dose 4', 'description': 'Participants will receive Dose 4 of KAI-9531 once weekly.', 'interventionNames': ['Drug: KAI-9531']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo matched to KAI-9531 once weekly.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KAI-9531', 'type': 'DRUG', 'description': 'SC Injection', 'armGroupLabels': ['KAI-9531: Dose 1', 'KAI-9531: Dose 2', 'KAI-9531: Dose 3', 'KAI-9531: Dose 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC Injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kailera Therapeutics, Inc.', 'role': 'CONTACT', 'email': 'info-clinicalstudies@kailera.com', 'phone': '781-317-0291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kailera', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}