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

ConditionObesity &Amp; Overweight
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorHK inno.N Corporation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IN-B00009

    Drug

    Test drug

  • Placebo

    Drug

    Placebo drug

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: IN-B00009Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in body weight from baseline at Week 40

Time frame
Baseline, 40 weeks
2

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

Time frame
Baseline, 40 weeks

Secondary outcomes

1

Percent change in body weight from baseline at Week 24

Time frame
Baseline, 24 weeks
2

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

Time frame
Baseline, 24 weeks
3

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

Time frame
Baseline, 24 weeks, 40 weeks
4

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

Time frame
Baseline, 24 weeks, 40 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HK inno.N Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: