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NCT06148649·Phase 2·INTERVENTIONAL

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

DulaglutideType 2 diabetesCompleted

Status

Completed

Phase

Phase 2

Enrollment

234

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

HEC88473, Placebo, Dulaglutide

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

Timeline

From registration to results.

  1. First posted

    Nov 28, 2023

  2. Study start

    Dec 10, 2023

  3. Primary completion

    Feb 27, 2025

  4. Study completion

    Apr 23, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Apr 29, 2025

Outcomes

What the study measures.

Primary outcomes

Change from baseline of HbA1c at week 12

Time frame · Baseline to week 12

HbA1c

Secondary outcomes

Change from baseline of weight at week 12

Time frame · Baseline to week 12

weight

Change from baseline of fasting blood-glucose at week 12

Time frame · Baseline to week 12

fasting blood-glucose

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)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University People's Hospital

Beijing, Beijing Municipality, China

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →