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

Last updated: April 26, 2025
Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

HEC88473, Placebo, Dulaglutide

Clinical Study ID

NCT06148649
HEC88473-DM-201
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 diagnosticcriteria (WHO 1999).

  3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, atscreening and visit 3.

Exclusion

Exclusion Criteria:

  1. Have type 1 diabetes mellitus.

  2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, orhistory of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3months).

  3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease otherthan 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 multipleendocrine 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 Design

Total Participants: 234
Treatment Group(s): 1
Primary Treatment: HEC88473, Placebo, Dulaglutide
Phase: 2
Study Start date:
December 10, 2023
Estimated Completion Date:
April 23, 2025

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

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