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

Overweight or Obesity Clinical Trial

Official title:

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440345
• Other study ID #: CIBI362B101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 16, 2020
• Est. completion date: August 6, 2021

Study information

• Verified date: November 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 6, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight or Obesity

Intervention

Drug:
• IBI362
Administered by subcutaneous injection
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
China	Peking University people's hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment adverse events	The relationship of each adverse event to the investigational product was assessed by the investigator.	From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
Secondary	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.	From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the Glucagon of IBI362 in overweight or obesity subjects;		From the first dose (Day 1 ) of study drug until 12 week
Secondary	Evaluate the Insulin of IBI362 in overweight or obesity subjects;		From the first dose (Day 1 ) of study drug until 12 week
Secondary	Evaluate the C-peptide of IBI362 in overweight or obesity subjects;		From the first dose (Day 1 ) of study drug until 12 week
Secondary	Change in body weight from baseline		Baseline (Day 1 ) and 12 week for groups