Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
NCT ID: NCT07284875
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1800 participants
INTERVENTIONAL
2025-12-31
2028-03-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KAI-9531: Dose 1
Participants will receive Dose 1 of KAI-9531 once weekly.
KAI-9531
SC Injection
KAI-9531: Dose 2
Participants will receive Dose 2 of KAI-9531 once weekly.
KAI-9531
SC Injection
KAI-9531: Dose 3
Participants will receive Dose 3 of KAI-9531 once weekly.
KAI-9531
SC Injection
KAI-9531: Dose 4
Participants will receive Dose 4 of KAI-9531 once weekly.
KAI-9531
SC Injection
Placebo
Participants will receive placebo matched to KAI-9531 once weekly.
Placebo
SC Injection
Interventions
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KAI-9531
SC Injection
Placebo
SC Injection
Eligibility Criteria
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Inclusion Criteria
1. hypertension,
2. dyslipidemia,
3. obstructive sleep apnea, or
4. cardiovascular (CV) disease.
* History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Exclusion Criteria
* 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.
* 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 cancer.
* 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 (MDD) or other severe psychiatric disorder.
* Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
18 Years
ALL
No
Sponsors
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Kailera
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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2025-523486-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
K9531-3103
Identifier Type: -
Identifier Source: org_study_id