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

Primary Purpose

Overweight or Obesity

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI362
Placebo
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IBI362

placebo

Arm Description

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.

Participants received matching placebo dose regiments by subcutaneous injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Anti-IBI362 Antibodies
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.
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
Evaluate the Insulin of IBI362 in overweight or obesity subjects;
Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
Change in body weight from baseline

Full Information

First Posted
June 5, 2020
Last Updated
July 11, 2021
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04440345
Brief Title
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Official Title
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Anticipated)
Study Completion Date
December 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Male and Female Subjects being Overweight or with Obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI362
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo dose regiments by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Number of treatment adverse events
Description
The relationship of each adverse event to the investigational product was assessed by the investigator.
Time Frame
From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
Secondary Outcome Measure Information:
Title
Number of Participants With Anti-IBI362 Antibodies
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.
Time Frame
From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
Title
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
Title
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
Title
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
Title
Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
Time Frame
From the first dose (Day 1 ) of study drug until 12 week
Title
Evaluate the Insulin of IBI362 in overweight or obesity subjects;
Time Frame
From the first dose (Day 1 ) of study drug until 12 week
Title
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
Title
Change in body weight from baseline
Time Frame
Baseline (Day 1 ) and 12 week for groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have stable body weight for the past 12 weeks prior to screening Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: Have a diagnosis of type 2 diabetes Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before. Surgical treatment for obesity 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 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 Unwilling to comply with smoking and alcohol restrictions during the study
Facility Information:
Facility Name
Peking University people's hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36247927
Citation
Ji L, Gao L, Jiang H, Yang J, Yu L, Wen J, Cai C, Deng H, Feng L, Song B, Ma Q, Qian L. 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. EClinicalMedicine. 2022 Oct 7;54:101691. doi: 10.1016/j.eclinm.2022.101691. eCollection 2022 Dec.
Results Reference
derived
PubMed Identifier
34430840
Citation
Ji L, Jiang H, An P, Deng H, Liu M, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L. 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. EClinicalMedicine. 2021 Aug 13;39:101088. doi: 10.1016/j.eclinm.2021.101088. eCollection 2021 Sep.
Results Reference
derived

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

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