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Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

NCT07192263•HK inno.N Corporation

View on ClinicalTrials.gov

Summary

This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus

Eligibility

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 19 to 75 years as of the date of written consent
•2. Those who meet any of the following obesity criteria at the screening visit
•* BMI ≥ 30 kg/m2
•* 27 kg/m2 ≤ BMI \< 30 kg/m2 with at least one risk factor or comorbidity
•* BMI (kg/m2) = weight (kg) / height (m)2
•* Hypertension: Taking antihypertensive medication or sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg
•* Dyslipidemia: Taking dyslipidemia medication or Total Cholesterol ≥ 240mg/dL or LDL-C ≥ 160 mg/dL or TG ≥ 200 mg/dL or HDL-C \< 40 mg/dL
•* Obstructive sleep apnea
•* Cardiovascular and cerebrovascular diseases: Ischemic cardiovascular and cerebrovascular diseases not corresponding to exclusion criterion 17, heart failure of NYHA Class I to III, etc.
•* Prediabetes: 100 mg/dL ≤ FPG ≤ 125 mg/dL or 140 mg/dL ≤ PG ≤ 199 mg/dL at 2 hours after 75 g oral glucose load or 5.7% ≤ HbA1c ≤ 6.4%
+3 more criteria

Exclusion Criteria

•1. Body weight change exceeding 5 kg within 3 months of the screening visit
•2. Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit
•3. Received any of the following medications or treatments within 3 months of the screening visit
•① Obesity-related medications (such as GLP-1 receptor agonists) or medications including over-the-counter drugs, herbal medicines, or health functional foods for weight control
•② Received hypoglycemic agent or requires continuous administration during the study period
•③ Received systemic steroids for 30 consecutive days or more, or requires continuous administration during the study period
•④ Received other medications that cause significant body weight changes or requires continuous administration during the study period (e.g.: antipsychotics, tricyclic antidepressants, selective serotonin reuptake inhibitors, noradrenergic and specific serotonergic antidepressant, mood stabilizers (lithium), anticonvulsants, serotonin antagonists, first-generation antihistamines, etc.)
•4. Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)
•5. Diagnosed with obesity due to genetic variations and congenital disorders
•* Obesity-causing genes: ob, db, Proopiomelanocortin (POMC), Melanocortin 4 receptor (MC4R) genes, etc.
+35 more criteria

Key Dates

Start Date

September 22, 2025

Primary Completion Date

December 31, 2026

Completion Date

September 30, 2027

Last Updated

September 25, 2025

Enrollment

300

ESTIMATED participants

Conditions

Obesity &Amp; Overweight

Interventions

IN-B00009

DRUG

Placebo

DRUG

Contacts

Eunji Park

CONTACT

82-031-5176-4656 eunji.park@inno-n.com

Eunji Kim

CONTACT

82-031-5176-4652 eunji.kim24@inno-n.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

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