Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.

Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HEC88473, Placebo, Dulaglutide

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: linong Ji, Doctor; Phone Number: 13910978815; Email: jiln@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Not yet recruiting
      • Peking University People's Hospital
      • Contact: Linong Ji, Doctor; Phone Number: 13910978815; Email: jiln@bimu.edu.cn
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • Shijiazhuang People's Hospital
      • Contact: Zhigang Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive.
2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.

Exclusion Criteria:

1. Have type 1 diabetes mellitus.
2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range at screening.
4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
5. Have serum calcitonin ≥20 ng/L at screening.
6. Fasted triglycerides > 5.7 mmol/L at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEC88473 dose1; T2DM subjects, receiving a weekly dose of HEC88473 dose1	Drug: HEC88473, Placebo, Dulaglutide; T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Experimental: HEC88473 dose2; T2DM subjects, receiving a weekly dose of HEC88473 dose2	Drug: HEC88473, Placebo, Dulaglutide; T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Experimental: HEC88473 dose3; T2DM subjects, receiving a weekly dose of HEC88473 dose3	Drug: HEC88473, Placebo, Dulaglutide; T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Placebo Comparator: Placebo; T2DM subjects, receiving a weekly dose of placebo	Drug: HEC88473, Placebo, Dulaglutide; T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Active Comparator: Dulaglutide; T2DM subjects, receiving a weekly dose of dulaglutide	Drug: HEC88473, Placebo, Dulaglutide; T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of HbA1c at week 12	HbA1c	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of weight at week 12	weight	Baseline to week 12
Change from baseline of fasting blood-glucose at week 12	fasting blood-glucose	Baseline to week 12
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to week 15

Collaborators and Investigators

• Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2023
• Primary Completion (Estimated): September 10, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: HEC88473-DM-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No