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Obesity &Amp; OverweightPhase 3NCT07192263

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

A Phase 3 study testing IN-B00009 in people with Obesity &Amp; Overweight, run by HK inno.N Corporation.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Obesity &Amp; Overweight
What is being tested?
IN-B00009
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
No sites listed yet
Study dates
22 Sep 2025to 30 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
Show all 13Show fewer
  • 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%
  • 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

Who cannot join

  • 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
Show all 45Show fewer
  • 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)
  • History (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or results of clinical laboratory test at the screening visit meeting the following:
  • Calcitonin ≥ 100 ng/L
  • TSH < 0.6 mIU/L or TSH > 6.8 mIU/L (However, subjects being treated for hypothyroidism with 0.6 mIU/L ≤ TSH ≤ 6.8 mIU/L, taking stable doses of thyroid hormonal preparation for 3 months prior to the screening visit and unlikely to have dose changes during the study period can participate)
  • History of acute or chronic pancreatitis, or results of clinical laboratory test at the screening visit meeting the following:
  • Amylase or Lipase > 3 times the upper limit of normal
  • Severe hepatic impairment or results of clinical laboratory test at the screening visit meeting the following:
  • AST or ALT > 3 times the upper limit of normal or Total bilirubin > 2 times the upper limit of normal
  • Severe renal impairment (eGFR < 30mL/min/1.73m2)
  • Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) at the screening visit
  • Answered "yes" to question 4 or 5 in the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or history of suicide attempt
  • Score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9) at the screening visit, or history of major depressive disorder with unstable state, anxiety, or other severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) within 2 years
  • History of alcohol addiction or drug abuse within 3 months of the screening visit
  • History of malignant tumor within the last 5 years
  • Those who have been determined as complete remission (CR, pCR) of the tumor and had no relapse for 5 years or more from the date of assessment can participate
  • Those with a history of thyroid cancer (excluding MTC), basal cell and squamous cell skin cancer within the last 5 years can participate
  • Any of the following medical histories confirmed within 3 months of the screening visit
  • Heart failure of NYHA class IV
  • Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
  • Ischemic heart disease (acute myocardial infarction, unstable angina, etc.). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion
  • Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion
  • History of non-arteritic anterior ischemic optic neuropathy (NAION)
  • History of resistance or hypersensitivity to investigational product class drugs (GLP analogues) or history of multi-drug allergies
  • Requires administration of contraindicated medications during the study period
  • Received other investigational products within 30 days or 5 times the half-life (whichever is longer) if the half-life is known, prior to the screening visit
  • Positive for HBsAg, HCV antibody, or HIV antibody at the screening visit
  • However, those who are HCV-Ab positive but confirmed negative in HCV-RNA test can participate
  • Hematological conditions that may interfere with HbA1c measurement (e.g.: hemolytic anemia, hemoglobinopathies)
  • Scheduled for surgery requiring hospitalization during the study period or requires surgical treatment
  • Positive pregnancy test, pregnant or lactating women
  • Considered inappropriate as a study subject by the investigator for other reasons

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Eunji Park contact

82-031-5176-4656

eunji.park@inno-n.com

Eunji Kim contact

82-031-5176-4652

eunji.kim24@inno-n.com

About this study

Official title: 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

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

Being tested
IN-B00009, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN-B00009Drug

    Test drug

  • PlaceboDrug

    Placebo drug

Study groups in NCT07192263
Study groupRoleWhat they receive
IN-B00009ExperimentalNot described
Receives: Drug: IN-B00009
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in body weight from baseline at Week 40

    Measured: Baseline, 40 weeks

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

    Measured: Baseline, 40 weeks

Secondary outcomes (12)

  1. Percent change in body weight from baseline at Week 24

    Measured: Baseline, 24 weeks

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

    Measured: Baseline, 24 weeks

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

    Measured: Baseline, 24 weeks, 40 weeks

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

    Measured: Baseline, 24 weeks, 40 weeks

  5. Change in body weight from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  6. Change in BMI from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  7. Change in waist circumference from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  8. Change in glucose metabolism parameters from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  9. Percent change in lipids from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  10. Change in blood pressure(systolic, diastolic) from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  11. Change in IWQOL-Lite-CT(Impact of Weight on Quality of Life-Lite for Clinical Trials version) (Physical function domain) from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

  12. Change in SF-36(36-Item Short Form Survey) scores from baseline at Week 24 and Week 40

    Measured: Baseline, 24 weeks, 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start22 Sep 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192263
Sponsor's protocol ID
IN_ECN_301
Status last verified
Sep 2025
First submitted
8 Sep 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IN-B00009 in people with Obesity &Amp; Overweight, run by HK inno.N Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eunji Park (82-031-5176-4656, eunji.park@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight from baseline at Week 40 (time frame: Baseline, 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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