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

Sponsor

Dongguan HEC Biopharmaceutical R&D Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06148649

Collaborator

(none)

225

Enrollment

Locations

Arms

9.7

Anticipated Duration (Months)

112.5

Patients Per Site

11.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: HEC88473, Placebo, Dulaglutide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Dec 10, 2023

Anticipated Primary Completion Date :

Sep 10, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of HbA1c at week 12 [Baseline to week 12]
HbA1c

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100044
2	Shijiazhuang People's Hospital	Shijiazhuang	Hebei	China	050000

Sponsors and Collaborators

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

ClinicalTrials.gov Identifier:

NCT06148649

Other Study ID Numbers:

HEC88473-DM-201

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Dulaglutide

Study Results

No Results Posted as of Nov 28, 2023