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NCT04466904·Phase 1 / Phase 2·INTERVENTIONAL

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

MazdutideType 2 diabetesCompleted

Status

Completed

Phase

Phase 1 / Phase 2

Enrollment

42

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention

Full detailed description

This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).

Interventions

Treatment arms and agents.

DRUG

IBI362

Administrated by subcutaneous injection

DRUG

Placebo

Administrated by subcutaneous injection

DRUG

Dulaglutide

Administrated by subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Jul 10, 2020

  2. Study start

    Sep 12, 2020

  3. Primary completion

    May 28, 2021

  4. Study completion

    May 28, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jul 23, 2021

Outcomes

What the study measures.

Primary outcomes

To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo

Time frame · From the first dose of study drug to week 19

Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period

Secondary outcomes

The PK/PD parameters of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the Glucagon of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the Insulin of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Evaluate the C-peptide of IBI362 in patients with T2DM

Time frame · From Baseline to week 12

Number of Participants With Anti-IBI362 Antibodies

Time frame · From the first dose of study drug to week 19

Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.

Eligibility

Who can take part.

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

\* Eligibility Criteria： Inclusion Criiteria: 1. Male or female 18 to 75 years of age at the time of consent. 2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months prior to screening. 3. HbA1c 7.5% ≤ 11.0% by local laboratory at screening. 4. Body mass index 20 ≤ BMI ≤ 35 kg/m2. Exclusion Criteria: 1. Type 1 diabetes, special types of diabetes, or gestational diabetes. 2. Ketoacidosis or lactic acidosis within 6 months prior to screening. 3. History of severe hypoglycaemic episodes within 6 months prior to screening. 4. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening. 5. Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) \> 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening. 6. The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.

Study locations

1 registered sites.

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

China Japan Friendship Hospital

Beijing, China

Publications

Results and literature.

PMID 35750681 ↗Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x.

Primary links

Continue at the source.

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

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