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

Innovent Biologics (Suzhou) Co. Ltd.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overweight or Obesity

Interventions

IBI362DRUG

Administered by subcutaneous injection

PlaceboDRUG

Administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University people's hospital

Beijing, China

Outcomes

Primary Outcomes

Number of treatment adverse events

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 Outcomes

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.

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

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