NCT06148649CompletedPhase 2
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 234 (actual)
- First submitted
- 20 Nov 2023
- Start date
- 10 Dec 2023
- Primary completion date
- 27 Feb 2025
- Lead sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06148649
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 234
- From 10 Dec 2023 to the primary completion date, 27 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Have type 1 diabetes mellitus.
- Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
Lab values
- 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 serum calcitonin ≥20 ng/L at screening.
- Fasted triglycerides \> 5.7 mmol/L at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.