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Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

NCT ID: NCT07284901

Last Updated: 2025-12-18

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-04-24

Brief Summary

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The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on:

* Percent change in body weight
* Change in hemoglobin A1c (HbA1c)

Detailed Description

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Conditions

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Obesity With Diabetes Overweight With Diabetes

Keywords

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Obesity Overweight KAI-9531 Glucagon-like peptide-1 GLP-1 Diabetes Glucose-dependent Insulinotropic Peptide GIP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KAI-9531: Dose 1

Participants will receive Dose 1 of KAI-9531 once weekly.

Group Type EXPERIMENTAL

KAI-9531

Intervention Type DRUG

SC Injection

KAI-9531: Dose 2

Participants will receive Dose 2 of KAI-9531 once weekly.

Group Type EXPERIMENTAL

KAI-9531

Intervention Type DRUG

SC Injection

KAI-9531: Dose 3

Participants will receive Dose 3 of KAI-9531 once weekly.

Group Type EXPERIMENTAL

KAI-9531

Intervention Type DRUG

SC Injection

KAI-9531: Dose 4

Participants will receive Dose 4 of KAI-9531 once weekly.

Group Type EXPERIMENTAL

KAI-9531

Intervention Type DRUG

SC Injection

Placebo

Participants will receive placebo matched to KAI-9531 once weekly.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC Injection

Interventions

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KAI-9531

SC Injection

Intervention Type DRUG

Placebo

SC Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 2 diabetes mellitus (T2DM).
* Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors.
* BMI ≥27 kg/m\^2.
* History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Exclusion Criteria

* Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
* History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
* 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
* History of suicide attempt.
* History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
* Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kailera

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Kailera Therapeutics, Inc.

Role: CONTACT

Phone: 781-317-0291

Email: [email protected]

Other Identifiers

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2025-523510-87-00

Identifier Type: CTIS

Identifier Source: secondary_id

K9531-3104

Identifier Type: -

Identifier Source: org_study_id