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

NCT04440345 | Completed Phase 1

• 1 other identifier: CIBI362B101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

• 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

Study Arms (2)

IBI362

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

Participants received matching placebo dose regiments by subcutaneous injection

Drug: Placebo

Interventions

IBI362 DRUG

Administered by subcutaneous injection

IBI362

Placebo DRUG

Administered by subcutaneous injection

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Peking University people's hospital

Beijing, China

Location

Related Publications (2)

• 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.

  PMID: 36247927 DERIVED

• 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.

  PMID: 34430840 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 19, 2020
• Study Start: June 16, 2020
• Primary Completion: June 16, 2021
• Study Completion: August 6, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CN (1)