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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: HEC88473, Placebo, Dulaglutide

• Registration Number: NCT06148649
• Lead Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-28
• Study Start: 2023-12-10
• Primary Completion: 2025-02-27
• Status Verified: 2025-04
• Study Completion: 2025-04-23
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC88473 dose1	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of HEC88473 dose1
HEC88473 dose2	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of HEC88473 dose2
Dulaglutide	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of dulaglutide
HEC88473 dose3	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of HEC88473 dose3
Placebo	HEC88473, Placebo, Dulaglutide	T2DM subjects, receiving a weekly dose of placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline of HbA1c at week 12	Baseline to week 12	HbA1c

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Shijiazhuang People's Hospital; 🇨🇳 Shijiazhuang, Hebei, China