A Study of TG103 in Subjects With Type 2 Diabetes

NCT04790006 | Unknown Phase 1

• 1 other identifier: SYSA1803-CSP-003
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessed by incidence and severity of adverse events

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  up to 15 weeks

Secondary Outcomes (7)

• Area under the plasma concentration versus time curve (AUC)

  Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78

• glycosylated hemoglobin (HbA1c)

  Day15, 29, 43, 57,71, and 78,

• The occurrence of TG103 anti-drug antibodies (ADA)

  up to 15 weeks

• Peak Plasma Concentration (Cmax),

  Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78

• Time to maximum plasma concentration (Tmax)

  Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78

Study Arms (2)

TG103

EXPERIMENTAL

TG103 will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Drug: TG103

Placebo

PLACEBO COMPARATOR

Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Drug: Placebo

Interventions

TG103 DRUG

Administered SC

TG103

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
• Age: 18 to 75 years of age inclusive; no gender limitation;
• \. Weight：body mass index (BMI) within the range of 18.5-35 kg/m2 (inclusive), BMI = weight (kg) / height 2 (m2);
• \. Patients have diagnosed with type 2 diabetes ≤ 3 years according to the World Health Organization (WHO1999) classification; and not on medication or without a history of regular medication for more than 1 week in the 3 months prior to screening (subjects with a history of medication only include those with a history of oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks));
• \. 7.0% ≤ HbA1c ≤ 10.0%;
• \. Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose;
• \. The subject has the ability to communicate properly with the researcher and willing to fully comply with the research protocol.

You may not qualify if:

• \. Fasting plasma glucose ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.2mmol/L);
• \. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening;
• \. During the screening period, the white blood cell count fall outside the reference range by 10%, or hemoglobin\<100g / L;
• \. Have one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum-specific antibody;
• \. Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) \> 2.5x upper limit of normal (ULN), or triglyceride \> 5.7mmol/L or eGFR\<60 mL/（min\*1.73 m2）during the screening period;
• \. Hypercortisolism, polycystic ovary syndrome, abnormal thyroid function (those who need to be given medication or who have not reached clinical stability after treatment and whose medication still needs to be adjusted), etc. or other diseases that may affect blood glucose metabolism.
• \. Have a personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer; personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer;
• \. Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
• \. Proliferative diabetic retinopathy, foot ulcers/gangrene, and manifestations of peripheral neuropathy with obvious symptoms (e.g., gastroparesis, urinary retention, intestinal obstruction, urinary incontinence, and painful peripheral neuropathy);
• \. Lost more than 400 ml of blood due to blood donation or other reasons within 3 months before the screening period;
• \. During 3 months prior to screening through the entire study period, subjects used or plan to use drugs that may affect blood glucose metabolism or directly reduce gastrointestinal motility (e.g., anticholinergic drugs, antispasmodic, 5-HT3 antagonists, dopamine antagonists, and opioids), or oral and intramuscular injections of systemic corticosteroids, or inhalation or intranasal use of potent steroidal drugs with high systemic absorption; subjects regularly used thiazide diuretics within the 3 months prior to screening (Continuous medication \> 1 week), or will use high doses of thiazide diuretics during the study period (hydrochlorothiazide\>100 mg/d, chlorothiazide\> 2 g/d, indapamide\> 5 mg/d, chlorthalidone\> 100 mg/d);
• \. During the screening period, subjects with second degree or third degree atrioventricular block (except for subjects who use the pacemaker), long QT syndrome or prolonged QTc interval (male\>450ms, female\>470ms), or those with significant clinical symptoms of ischemic heart disease; or those with other heart diseases that are judged by the investigator to be unsuitable for entry into the study;
• \. Any of the following cardiovascular and cerebrovascular events within half a year before screening: unstable angina pectoris requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography is allowed), moderate to severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (such as atrial fibrillation and ventricular tachycardia). Subjects with pacemaker or defibrillator implantation, transient ischemic attack or cerebrovascular accident (e.g. stroke), or those with coronary artery bypass grafting or revascularization planned during the study period;
• \. Have chronic or acute pancreatitis ( or have a history of chronic pancreatitis or acute pancreatitis) or severe gastrointestinal disease, such as confirmed reflux esophagitis or gallbladder disease, or any impact on gastric emptying (such as gastric bypass surgery, pyloric stenosis, except for appendectomy) or gastrointestinal diseases that may be aggravated by GLP-1 analogues; for patients with a history of gallbladder stones (gallstone removal or lithotripsy) and/or cholecystectomy, if there are no further sequelae, the entering of the study will be determined by researchers after assessing the risk;
• \. Have had undergone major surgery within 3 months before screening, or had ongoing severe or acute infection within 4 weeks before screening;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Wenying Yang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaoran Song

CONTACT

0311-69085931; songjiaoran@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share