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

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

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: Placebo; Drug: IBI362

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IBI362; Administered by subcutaneous injection
Placebo Comparator: placebo; Participants received matching placebo dose regiments by subcutaneous injection	Drug: Placebo; Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 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 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 Insulin of IBI362 in overweight or obesity subjects;		From the first dose (Day 1 ) of study drug until 12 week
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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): June 16, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: CIBI362B101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No