A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
NCT ID: NCT05943886
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
164 participants
INTERVENTIONAL
2021-08-11
2023-02-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of ZT002 Injection With Subjects With Overweight or Obesity
NCT07020884
Phase Ia Clinical Study of HDM1005 Injection
NCT06640647
A Study of HS-20094 in Chinese Adults with Overweight or Obesity
NCT06839664
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection
NCT06934408
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.
NCT07121153
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single dose of 0.5 mg HEC88473
Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 1.7 mg HEC88473
Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 5.1 mg HEC88473
Healthy 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.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 10.2 mg HEC88473
Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 17.0 mg HEC88473
Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 25.5 mg HEC88473
Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 35.7 mg HEC88473
Healthy subjects, receiving a single dose of 35.7 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 47.6 mg HEC88473
Healthy subjects, receiving a single dose of 47.6 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 62.9 mg HEC88473
Healthy subjects, receiving a single dose of 62.9 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Single dose of 81.6 mg HEC88473
Healthy subjects, receiving a single dose of 81.6 mg HEC88473 (N=8) or placebo(N=2) after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Multiple doses of 5.1 mg HEC88473
T2DM subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Multiple doses of 15.3 mg HEC88473
T2DM subjects, receiving a weekly dose of 15.3 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Multiple doses of 30.6 mg HEC88473
T2DM 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.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Multiple doses of 45.9 mg HEC88473
T2DM 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.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Multiple doses of 68.0 mg HEC88473
T2DM 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.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
Placebo
Placebo will be administered by subcutaneous injection in the abdomen.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Males or females, between 18 and 45 years of age, inclusive, at screening.
2. 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
1. Males or females, between 18 and 65 years of age, inclusive, at screening.
2. 24 kg/m2≤BMI≤35 kg/m2.
3. 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.
4. 7.0%≤ HbA1c ≤10.5% at screening.
Exclusion Criteria
1. Smoked more than 5 cigarettes per day within 3 months before the study.
2. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.
3. Positive alcohol breath test result or positive urine drug screen.
4. Blood donation (\> 300 mL) or massive blood loss (\> 400 mL) within 3 months before screening.
Part B
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 \>5 times the upper limit of the reference range at screening.
4. Have serum calcitonin ≥20 ng/L at screening.
5. 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.
6. 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yanhua Ding, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Hospital of Jilin University
Changchun, Jilin, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEC88473-DM-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.