Type 2 DiabetesPhase 2NCT06148649
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study of Type 2 Diabetes, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 2 sitesChina
- Study dates
- 10 Dec 2023to 23 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050000
About this study
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
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).
- Conditions
- Type 2 Diabetes
- Being tested
- HEC88473, Placebo, Dulaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC88473, Placebo, DulaglutideDrug
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
| Study group | Role | What they receive |
|---|---|---|
| HEC88473 dose1 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose1 Receives: Drug: HEC88473, Placebo, Dulaglutide |
| HEC88473 dose2 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose2 Receives: Drug: HEC88473, Placebo, Dulaglutide |
| HEC88473 dose3 | Experimental | T2DM subjects, receiving a weekly dose of HEC88473 dose3 Receives: Drug: HEC88473, Placebo, Dulaglutide |
| Placebo | Placebo comparator | T2DM subjects, receiving a weekly dose of placebo Receives: Drug: HEC88473, Placebo, Dulaglutide |
| Dulaglutide | Active comparator | T2DM subjects, receiving a weekly dose of dulaglutide Receives: Drug: HEC88473, Placebo, Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of HbA1c at week 12
HbA1c
Measured: Baseline to week 12
Secondary outcomes (3)
Change from baseline of weight at week 12
weight
Measured: Baseline to week 12
Change from baseline of fasting blood-glucose at week 12
fasting blood-glucose
Measured: Baseline to week 12
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline to week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start10 Dec 2023
- Primary completion27 Feb 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148649
- Sponsor's protocol ID
- HEC88473-DM-201
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06148649
- Acronym / sponsor ID
- HEC88473-DM-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HEC88473 dose1 | Experimental | Drug: HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of HEC88473 dose1 |
| HEC88473 dose2 | Experimental | Drug: HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of HEC88473 dose2 |
| HEC88473 dose3 | Experimental | Drug: HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of HEC88473 dose3 |
| Placebo | Placebo comparator | Drug: HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of placebo |
| Dulaglutide | Active comparator | Drug: HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of dulaglutide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC88473, Placebo, DulaglutideT2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide. | Drug | Dulaglutide, HEC88473 dose1, HEC88473 dose2, HEC88473 dose3, Placebo |
Primary outcome
Change from baseline of HbA1c at week 12
Time frame: Baseline to week 12
HbA1c
3 secondary outcomes
Change from baseline of weight at week 12
Time frame: Baseline to week 12
Change from baseline of fasting blood-glucose at week 12
Time frame: Baseline to week 12
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to week 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 2 Diabetes, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of HbA1c at week 12 (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.