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

NCT07192263 | Not Yet Recruiting Phase 3

• 1 other identifier: IN_ECN_301
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (2)

• Percent change in body weight from baseline at Week 40

  Baseline, 40 weeks

• Proportion of subjects with ≥5% body weight loss from baseline at Week 40

  Baseline, 40 weeks

Secondary Outcomes (12)

• Percent change in body weight from baseline at Week 24

  Baseline, 24 weeks

• Proportion of subjects with ≥5% body weight loss from baseline at Week 24

  Baseline, 24 weeks

• Proportion of subjects with ≥10% body weight loss from baseline at Week 24 and Week 40

  Baseline, 24 weeks, 40 weeks

• Proportion of subjects with ≥15% body weight loss from baseline at Week 24 and Week 40

  Baseline, 24 weeks, 40 weeks

• Change in body weight from baseline at Week 24 and Week 40

  Baseline, 24 weeks, 40 weeks

Study Arms (2)

IN-B00009

EXPERIMENTAL

Drug: IN-B00009

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IN-B00009 DRUG

Test drug

IN-B00009

Placebo DRUG

Placebo drug

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 to 75 years as of the date of written consent
• Those who meet any of the following obesity criteria at the screening visit
• BMI ≥ 30 kg/m2
• 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
• 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%
• Self-reported history of at least one failed attempt at weight control using diet and exercise therapy prior to the screening visit
• Able to agree to and follow the reduced-calorie diet and exercise therapy recommended in this study during the study period
• Agrees to use a medically appropriate method of contraception (including medically infertile conditions) during the study period

You may not qualify if:

• Body weight change exceeding 5 kg within 3 months of the screening visit
• Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit
• 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.)
• Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)
• Diagnosed with obesity due to genetic variations and congenital disorders
• Obesity-causing genes: ob, db, Proopiomelanocortin (POMC), Melanocortin 4 receptor (MC4R) genes, etc.
• Congenital disorders: Prader-Willi syndrome, Laurence-Moon-Biedl syndrome, Alström syndrome, Cohen syndrome, Carpenter syndrome, etc.
• History of bariatric surgery (e.g., adjustable gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion/duodenal switch, etc.) or device procedures, or plans for such during the study period
• However, those who have had devices (e.g., gastric band, intragastric balloon) removed for more than 1 year can participate
• Those who have had liposuction or abdominoplasty for more than 1 year can participate
• Clinically significant gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction, peptic ulcer, severe gastroesophageal reflux disease)

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheol-Young Park

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 25, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share