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NCT04440345·Phase 1 / Phase 2·INTERVENTIONAL

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

MazdutideWeight lossCompleted

Status

Completed

Phase

Phase 1 / Phase 2

Enrollment

60

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

IBI362

Administered by subcutaneous injection

DRUG

Placebo

Administered by subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Jun 19, 2020

  2. Study start

    Jun 16, 2020

  3. Primary completion

    Jun 16, 2021

  4. Study completion

    Aug 6, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Nov 28, 2023

Outcomes

What the study measures.

Primary outcomes

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

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.

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

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

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

Evaluate the Glucagon of IBI362 in overweight or obesity subjects;

Time frame · From the first dose (Day 1 ) of study drug until 12 week

Evaluate the Insulin of IBI362 in overweight or obesity subjects;

Time frame · From the first dose (Day 1 ) of study drug until 12 week

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

Change in body weight from baseline

Time frame · Baseline (Day 1 ) and 12 week for groups

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University people's hospital

Beijing, China

Publications

Results and literature.

PMID 36247927 ↗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 34430840 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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