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Trial · Interventional

Active, not recruitingPhase 1/2Registry data

Tolerance 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
2025202620272028
  1. Ph 1/2

    Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

    NCT07000955

    17 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.

  1. The Incidence of adverse events and serious adverse events during the treatment period

    Time frame · week 44

  2. The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame · week 44

  3. The incidence rates of Adverse Event of Special Interest

    Time frame · week 44

  4. The value of systolic and diastolic pressures

    Time frame · week 44

  5. 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

  6. 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

  7. The value of pulse rate

    Time frame · week 44

Secondary outcomes(15)
  1. Evaluate the pharmacokinetic (PK) characteristics of IBI362

    Time frame · week 44

    Registry description

    Maximum Plasma Concentration Area under the concentration-time curve

  2. The change in body weight from baseline

    Time frame · week 44

  3. Immunogenicity

    Time frame · week 44

    Registry description

    The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab)

  4. The change in waist circumference from baseline

    Time frame · week 44

  5. 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

  6. Changes and percentage changes of liver fat content compared with the baseline

    Time frame · week 44

  7. 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

  8. The change in body-mass index from baseline

    Time frame · week 44

  9. The change in neck circumference from baseline

    Time frame · week 44

  10. The change in hip circumference from baseline

    Time frame · week 44

  11. The change in waist circumference/hip circumference ratio from baseline

    Time frame · week 44

  12. Changes in hemoglobin A1c (HbA1c%) , from baseline

    Time frame · week 44

  13. Changes in fasting blood glucose , from baseline

    Time frame · week 44

  14. Changes in Fasting insulin, from baseline

    Time frame · week 44

  15. 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
Inclusion Criteria: * 1\. The age at the time of screening is 18 to 55 years old (including both ends), male or female; * 2\. BMI≥32.5 kg/m2 during screening; * 3\. At the time of screening, after simple diet and exercise control for at least 12 weeks, the weight change was less than 5% \[(Maximum weight within 3 months before screening - minimum weight within 3 months before screening)/maximum weight within 3 months before screening ×100%, self-reported by the subjects\] * 4\. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and within 3 months after the last treatment. Female subjects with reproductive capacity must have negative pregnancy test results during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment; * 5\. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions in the informed consent form and protocol throughout the research period, including but not limited to: diet, exercise, lifestyle management, planned injection of research drugs, keeping research diaries, and completing relevant questionnaires, etc; Exclusion Criteria: * 1\. The investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution; * 2\. Use any of the following drugs or treatments within 3 months before screening including but not limited to GLP-1R, GIPR, GCGR, any drugs, Chinese herbal medicines, health supplements or meal replacements that have an impact on body weight, or participated in other clinical trials; * 3\. There is a history or evidence of any of the following diseases before screening or at the time of screening including but not limited to diabetes, have received or plan to undergo bariatric surgery during the research period in the past, with retinopathy in the past or at the time of screening, secondary diseases or drugs lead to obesity, have a history of depression in the past or have a history of serious mental illness in the past, hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment, a history of malignant tumors was present during the screening, heart disease, A 2A or 2B history or family history of medullary thyroid carcinoma and multiple endocrine adenomatosis (MEN) , history of acute and chronic pancreatitis, limb deformity or disability, have a history of suicidal tendencies or suicidal behaviors, etc according to the protocol. * 4\. Any of the laboratory examination indicators meets the following standards during screening: serum calcitonin ≥20ng/L during screening, alanine aminotransferase ≥2.0×ULN and/or aspartate aminotransferase ≥2.0×ULN and/or total bilirubin ≥1.5×ULN and/or alkaline phosphatase ≥2.0×ULN, eGFR is less than 60 Ml/min/1.73 m2, abnormal thyroid function including FT3, FT4, or TSH, fasting triglycerides ≥5.64 mmol/L (500 mg/dl), blood amylase or lipase 1.0 x ULN; * 5\. During the screening, the 12-lead electrocardiogram showed a heart rate of \<50 beats per minute or \>90 beats per minute; * 6\. There were clinically significant ECGs abnormalities during the screening; * 7\. History of other risk factors for tachycardia; * 8\. The blood donation volume and/or blood loss volume within 3 months prior to screening is ≥400mL, or bone marrow donation has been performed, or there are anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, etc., or hemoglobin.. 110g/ L (male) or 100g/L (females). * 9\. The investigators believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study and are not suitable to participate in this study.

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