Trial · Interventional
Active, not recruitingPhase 1/2Registry dataTolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
Overview
- Status
- Active, not recruiting
- Phase
- Phase 1/2
- Enrollment
- 98 participants (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
China
- Start
- 17 Jun 2025
- Primary completion
- 30 Sept 2026 (estimated)
- Completion
- 14 May 2027 (estimated)
- First posted
- 3 Jun 2025
- Last update posted
- 15 Dec 2025
- Conditions
- Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1/2
Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
NCT0700095517 Jun 2025 to est. 14 May 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study
Interventions
- TirzepatideDrug
- PlaceboDrug
- IBI362Drug
Arms3
Experimental
IBI362
Stage 1: subcutaneous injection, qw; dose ranging from 2.0mg to 15.0mg,44w Stage 2: subcutaneous injection, q2w; 12.0mg or 15.0mg, 12w;
Placebo comparator
Placebo
Stage 1: subcutaneous injection, 0mg, qw, 44w Stage 2: subcutaneous injection, dose ranging from 2.0mg to 6.0mg,qw, 12w
Active comparator
Tirzepatide
Open label: subcutaneous injection, qw, dose ranging from 2.5mg to 15.0mg, 44w
Primary outcomes7
Outcomes the sponsor listed as primary.
The Incidence of adverse events and serious adverse events during the treatment period
Time frame · week 44
The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame · week 44
The incidence rates of Adverse Event of Special Interest
Time frame · week 44
The value of systolic and diastolic pressures
Time frame · week 44
The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram
Time frame · week 44
Any adverse event evaluated by laboratory examinations
Time frame · week 44
Registry description
Including amylase, lipase, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], calcitonin, urinary albumin-to-creatinine ratio \[UACR\], creatine kinase \[CK\], lactate dehydrogenase \[LDH\], etc
The value of pulse rate
Time frame · week 44
Secondary outcomes(15)
Evaluate the pharmacokinetic (PK) characteristics of IBI362
Time frame · week 44
Registry description
Maximum Plasma Concentration Area under the concentration-time curve
The change in body weight from baseline
Time frame · week 44
Immunogenicity
Time frame · week 44
Registry description
The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab)
The change in waist circumference from baseline
Time frame · week 44
Changes and percentage changes of abdominal visceral fat (VAT) content, abdominal subcutaneous fat (SAT) content, and abdominal total fat (TAAT) content relative to the baseline
Time frame · week 44
Changes and percentage changes of liver fat content compared with the baseline
Time frame · week 44
The changes in insulin resistance index (HOMA2-IR) and islet β-cell function index (HOMA2-B) from baseline calculated by the concentration of fasting blood glucose and the concentration of fasting insulin
Time frame · week 44
The change in body-mass index from baseline
Time frame · week 44
The change in neck circumference from baseline
Time frame · week 44
The change in hip circumference from baseline
Time frame · week 44
The change in waist circumference/hip circumference ratio from baseline
Time frame · week 44
Changes in hemoglobin A1c (HbA1c%) , from baseline
Time frame · week 44
Changes in fasting blood glucose , from baseline
Time frame · week 44
Changes in Fasting insulin, from baseline
Time frame · week 44
Changes in Fasting C-peptide, from baseline
Time frame · week 44
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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