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Completed

NCT Number: NCT04440345

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

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University people's hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBI362

Drug

Administered by subcutaneous injection

Placebo

Drug

Administered by subcutaneous injection

Primary outcomes

  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)

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

Secondary outcomes

  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)

    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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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