NCT06148649

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

November 20, 2023

Last Update Submit

April 26, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of HbA1c at week 12

    HbA1c

    Baseline to week 12

Secondary Outcomes (3)

  • Change from baseline of weight at week 12

    Baseline to week 12

  • Change from baseline of fasting blood-glucose at week 12

    Baseline to week 12

  • Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Baseline to week 15

Study Arms (5)

HEC88473 dose1

EXPERIMENTAL

T2DM subjects, receiving a weekly dose of HEC88473 dose1

Drug: HEC88473, Placebo, Dulaglutide

HEC88473 dose2

EXPERIMENTAL

T2DM subjects, receiving a weekly dose of HEC88473 dose2

Drug: HEC88473, Placebo, Dulaglutide

HEC88473 dose3

EXPERIMENTAL

T2DM subjects, receiving a weekly dose of HEC88473 dose3

Drug: HEC88473, Placebo, Dulaglutide

Placebo

PLACEBO COMPARATOR

T2DM subjects, receiving a weekly dose of placebo

Drug: HEC88473, Placebo, Dulaglutide

Dulaglutide

ACTIVE COMPARATOR

T2DM subjects, receiving a weekly dose of dulaglutide

Drug: HEC88473, Placebo, Dulaglutide

Interventions

HEC88473, Placebo, DulaglutideDRUG

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

DulaglutideHEC88473 dose1HEC88473 dose2HEC88473 dose3Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

December 10, 2023

Primary Completion

February 27, 2025

Study Completion

April 23, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)