Clinical trial NCT04440345: Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Official title: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight or Obesity
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment adverse events
timeFrame: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
Secondary outcomes:
measure: Number of Participants With Anti-IBI362 Antibodies
timeFrame: From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
measure: Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the Insulin of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
timeFrame: From the first dose (Day 1 ) of study drug until 12 week
measure: Change in body weight from baseline
timeFrame: Baseline (Day 1 ) and 12 week for groups
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University people's hospital
Study officials:
References:
citation: 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.
citation: 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.