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Trial · Interventional

CompletedPhase 1/2Registry data

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

NCTNCT04440345 (opens ClinicalTrials.gov in a new tab)Other idCIBI362B101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
60 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
16 Jun 2020
Primary completion
16 Jun 2021
Completion
6 Aug 2021
First posted
19 Jun 2020
Last update posted
28 Nov 2023
Conditions
Overweight or Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 1/2

    Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

    NCT04440345

    16 Jun 2020 to 6 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.

Interventions

  • IBI362Drug
  • PlaceboDrug

Arms2

  • Experimental

    IBI362

    Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.

  • Placebo comparator

    placebo

    Participants received matching placebo dose regiments by subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment adverse events

    Time frame · From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)

    Registry description

    The relationship of each adverse event to the investigational product was assessed by the investigator.

Secondary outcomes(8)

  1. Number of Participants With Anti-IBI362 Antibodies

    Time frame · From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)

    Registry description

    Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.

  2. Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  3. Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  4. Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  5. Evaluate the Glucagon of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  6. Evaluate the Insulin of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  7. Evaluate the C-peptide of IBI362 in overweight or obesity subjects;

    Time frame · From the first dose (Day 1 ) of study drug until 12 week

  8. Change in body weight from baseline

    Time frame · Baseline (Day 1 ) and 12 week for groups

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.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2022

8 results

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial.

Ji et al. 2022EClinicalMedicinecited by 66

PMID 36247927PMC9561728DOI 10.1016/j.eclinm.2022.101691PUB-36247927

CC BY8 results
Download PDFSee results (8)

PubMed tag: none · 2021

8 results

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study.

Ji et al. 2021EClinicalMedicinecited by 42

PMID 34430840PMC8374649DOI 10.1016/j.eclinm.2021.101088PUB-34430840

CC BY8 results
Download PDFSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Have stable body weight for the past 12 weeks prior to screening 2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening 3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: 1. Have a diagnosis of type 2 diabetes 2. Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening 3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before. 4. Surgical treatment for obesity 5. Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL 6. Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study 7. Unwilling to comply with smoking and alcohol restrictions during the study

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