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

Phase 1

Completed

• Conditions: Overweight or Obesity
• Interventions: Drug: Placebo; Drug: IBI362

• Registration Number: NCT04440345
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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 Overweight or Obese Male and Female Subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-05
• Study Start: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Primary Completion: 2021-06-16
• Study Completion: 2021-08-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Participants received matching placebo dose regiments by subcutaneous injection
IBI362	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.

Primary Outcome Measures

Name	Time	Method
Number of treatment adverse events	From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)	The relationship of each adverse event to the investigational product was assessed by the investigator.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Anti-IBI362 Antibodies	From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)	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 C-peptide of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week
Change in body weight from baseline	Baseline (Day 1 ) and 12 week for groups
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Glucagon of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Insulin of IBI362 in overweight or obesity subjects;	From the first dose (Day 1 ) of study drug until 12 week

Trial Locations

Locations (1)

Peking University people's hospital; 🇨🇳 Beijing, China