A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

NCT06256549
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Participants
272
clinicaltrials.gov
Lead sponsor
Gan and Lee Pharmaceuticals, USA
clinicaltrials.gov
Start date
2023-08-09
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.
clinicaltrials.gov
Short title
A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
clinicaltrials.gov
Official title
A Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2024-07-20
clinicaltrials.gov
First posted
2024-02-13
clinicaltrials.gov
Registry last updated
2024-02-23
clinicaltrials.gov
Primary completion date
2024-07-20
clinicaltrials.gov
Start date
2023-08-09
clinicaltrials.gov

Actual participants
272
clinicaltrials.gov
Participants
272
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Gan and Lee Pharmaceuticals, USA
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06256549
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06256549
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks

    Timeframe: 24 weeks

  1. HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)

    Timeframe: 24 weeks

    Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks

  2. The overall incidence of adverse events and the incidence of serious adverse events

    Timeframe: 27 weeks

    Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • (1) Chinese adults, male or female aged between 18 and 75 (including both ends).

    (2) According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.

    (3) Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.

    (4) HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.

    (5) Body mass index (BMI) ≥ 18.5 kg/m2.

    (6) There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.

    (7) Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.

  • (1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.

    (2) Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.

    (3) Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.

    (4) History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).

    (5) Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.

    (6) Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.

    (7) Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.

Sources for eligibility
clinicaltrials.gov

  • Gan & Lee Pharmaceuticals Co., LtdBeijing, China
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)