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OpenTrials
Completed

NCT Number: NCT06148649

Phase 2 Study 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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Have type 1 diabetes mellitus.
  • 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).
  • 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.
  • Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
  • Have serum calcitonin ≥20 ng/L at screening.
  • Fasted triglycerides > 5.7 mmol/L at screening.

Treatment and study plan

HEC88473, Placebo, Dulaglutide

Drug

T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.

Primary outcomes

  1. Change from baseline of HbA1c at week 12

    Time frame: Baseline to week 12

    HbA1c

Secondary outcomes

  1. Change from baseline of weight at week 12

    Time frame: Baseline to week 12

    weight

  2. Change from baseline of fasting blood-glucose at week 12

    Time frame: Baseline to week 12

    fasting blood-glucose

  3. Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline to week 15

    Adverse Events (AEs) and Serious Adverse Events (SAEs)

Sponsors and collaborators

Lead sponsor

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2023
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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