A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

NCT06553248 | Completed Phase 1

• 1 other identifier: GL-GZR-CH1016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes

Conditions

Diabetes

Keywords

GZR4; PK; PD

Outcome Measures

Primary Outcomes (1)

• Incidence of TEAE

  Baseline to Week 6

Secondary Outcomes (5)

• AUC0-inf

  Week 6

• AUC0-last

  Week 6

• AUC0-168h

  Week 1, Week 6

• Tmax,GZR4

  Week 1, Week 6

• ADA of GZR4

  Baseline to Week 10

Study Arms (2)

GZR4

EXPERIMENTAL

s.c., once weekly

Drug: GZR4

Insulin Degludec

ACTIVE COMPARATOR

s.c., once daily

Drug: Insulin Degludec

Interventions

GZR4 DRUG

Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks

GZR4

Insulin Degludec DRUG

Administered once daily subcutaneously (s.c., under the skin) for 6 weeks

Insulin Degludec

Eligibility Criteria

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

You may qualify if:

• Male or female at the age of 18-65 (inclusive) at the time of informed consent
• Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
• Diagnosis of type 2 diabetes mellitus for over 3 months
• Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.

You may not qualify if:

• History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
• Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
• Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
• Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
• Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 14, 2024
• Study Start: March 22, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)