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Healthy SubjectsPhase 1NCT05943886

A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

A Phase 1 study testing HEC88473 injection in people with Healthy Subjects and Obesity, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
HEC88473 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteChina
Study dates
11 Aug 2021to 17 Feb 2023
Phase
Phase 1
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A
  • Males or females, between 18 and 45 years of age, inclusive, at screening.
  • Body weight ≥ 50 kg for males and body weight ≥ 45 kg for females. 18≤body mass index (BMI)<28 kg/m2 for nonobese subjects and 28≤BMI≤45 kg/m2 for obese subjects.
  • Part B
  • Males or females, between 18 and 65 years of age, inclusive, at screening.
  • 24 kg/m2≤BMI≤35 kg/m2.
  • Subjects diagnosed with T2DM, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for ≥ 3 months before screening.
  • 7.0%≤ HbA1c ≤10.5% at screening.

Who cannot join

  • Part A
  • Smoked more than 5 cigarettes per day within 3 months before the study.
  • Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.
  • Positive alcohol breath test result or positive urine drug screen.
  • Blood donation (> 300 mL) or massive blood loss (> 400 mL) within 3 months before screening.
  • Part B
Show all 12Show fewer
  • 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 >5 times the upper limit of the reference range at screening.
  • Have serum calcitonin ≥20 ng/L at screening.
  • Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce MTC.
  • Fasted triglycerides > 5.7 mmol/L at screening. If the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

Other trials in China

About this study

Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).

Read the detailed description

This study is divided into two parts, Part A is an escalating single-dose study in healthy subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with T2DM.

Being tested
HEC88473 injection, Placebo
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEC88473 injectionDrug

    HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.

  • PlaceboDrug

    Placebo will be administered by subcutaneous injection in the abdomen.

Study groups in NCT05943886
Study groupRoleWhat they receive
Single dose of 0.5 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 1.7 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 5.1 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=8) or placebo(N=2) after meal. Obese subjects, receiving a single dose of 5.1 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 10.2 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 17.0 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 25.5 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 35.7 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 35.7 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 47.6 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 47.6 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 62.9 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 62.9 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 81.6 mg HEC88473ExperimentalHealthy subjects, receiving a single dose of 81.6 mg HEC88473 (N=8) or placebo(N=2) after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 5.1 mg HEC88473ExperimentalT2DM subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 15.3 mg HEC88473ExperimentalT2DM subjects, receiving a weekly dose of 15.3 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 30.6 mg HEC88473ExperimentalT2DM subjects, receiving a weekly dose of HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. The 30.6 mg cohort was administered by titration.
Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 45.9 mg HEC88473ExperimentalT2DM subjects, receiving a weekly dose of HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. The 45.9 mg cohort was administered by titration.
Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 68.0 mg HEC88473ExperimentalT2DM subjects, receiving a weekly dose of HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. The 68.0 mg cohort was administered by titration.
Receives: Drug: HEC88473 injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473

    Adverse Events (AEs)

    Measured: Baseline to day 15

  2. Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473

    Adverse Events (AEs)

    Measured: Baseline to day 43

  3. Cmax

    Maximum observed serum concentration of HEC88473

    Measured: Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours

  4. AUC

    Area under the serum concentration-time curve (AUC)

    Measured: Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours

Secondary outcomes (5)

  1. OGTT

    Oral glucose tolerance test

    Measured: Day-1, Day3 and Day 7

  2. Change from baseline of Adiponectin at day 38

    Adiponectin

    Measured: Baseline to day 38

  3. Fasting lipid concentration

    Fasting lipid concentration

    Measured: Baseline to day 43

  4. Change from baseline of HbA1c at day 38

    HbA1c

    Measured: Baseline to day 38

  5. Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing

    anti drug antibodies (ADA)

    Measured: Baseline to day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start11 Aug 2021
  3. Primary completion17 Feb 2023
  4. Study completion17 Feb 2023

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943886
Sponsor's protocol ID
HEC88473-DM-101
Status last verified
Jul 2023
First submitted
5 Jul 2023
Last updated
17 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang H, Li Q, Chen H, Guo L, Li J, Xie C, Yan J, Ding Y. First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects. BioDrugs. 2025 May;39(3):477-486. doi: 10.1007/s40259-025-00715-3. Epub 2025 Apr 3.

    PubMed 40175670

  • Xiang L, Wang G, Zhuang Y, Luo L, Yan J, Zhang H, Li X, Xie C, He Q, Peng Y, Chen H, Li Q, Li X, Guo L, Lv G, Ding Y. Safety and efficacy of GLP-1/FGF21 dual agonist HEC88473 in MASLD and T2DM: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jun;82(6):967-978. doi: 10.1016/j.jhep.2024.12.006. Epub 2024 Dec 19.

    PubMed 39709140

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEC88473 injection in people with Healthy Subjects and Obesity, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 1 site 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 8 inclusion and 12 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473 (time frame: Baseline to day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05943886, which also lists 2 linked publications.

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 17 Jul 2023.

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