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Type 2 Diabetes PatientsPhase 1/2NCT04662164

A Study to Access the Efficacy in Type 2 Diabetes Mellitus on Stable Metformin

A Phase 1/2 study testing hepalatide in people with Type 2 Diabetes Patients, run by Shanghai HEP Pharmaceutical Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, repeat-dose study to evaluate the safety, tolerability, PK, and PD of L47 as an add-on treatment to stable metformin therapy in patients with T2DM. Approximately 30 subjects will be randomized into the study at up to two investigational sites. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Patients
What is being tested?
hepalatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2025to Dec 2025
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have received a diagnosis of T2DM ≥3 months prior to screening
  • Subjects who have taken a stable metformin dose for at least one month prior to screening and are not currently taking other anti-diabetic drugs
  • Males or females between 18 and 70 years of age, inclusive. Females must have agreed to use appropriate birth control throughout the study or be surgically sterile (hysterectomy, tubal ligation, bilateral oophorectomy) or post-menopausal for 1 year (with follicle stimulating hormone in menopausal range). A serum pregnancy test was performed for women of childbearing potential at the screening visit and at Day -1.
  • Male patients with sexual partners of childbearing potential and female patients of childbearing potential must have agreed to use 1 of the following contraception methods:
  • One form of barrier method contraception (eg, latex condom with spermicide or a diaphragm with intravaginal spermicide or cervical cap with spermicide) in addition to a male patient's female partner(s) taking an oral contraceptive; or
  • Two forms of barrier method contraception (eg, latex condom with spermicide AND a diaphragm with intravaginal spermicide or cervical cap with spermicide);
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  • Subjects who have a body mass index ≥19 kg/m2 and ≤35 kg/m2
  • Subjects who have a Hemoglobin A1c(HBA1c) ≥6.5% and ≤10.5%, as assessed by the central laboratory
  • Current non-smokers who have not used tobacco or nicotine in any form at least 6 months prior to dosing
  • Currently have not used nicotine and non-nicotine vaping/electronic cigarette products in the last 6 months
  • Fasting plasma glucose >110 mg/dL and <240 mg/dL;
  • Willing and able to be confined to the investigational site as required by the protocol;
  • Willing and able to comply with the investigational nature of the study and able to communicate well with the Principal Investigator and clinical staff; and
  • Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.

Who cannot join

  • Have a condition that is a contraindication for use of metformin per Label at screening or at baseline visit;
  • History of type 1 diabetes mellitus, or latent autoimmune diabetes in adults, diabetic neuropathy, retinopathy or nephropathy
  • History of renal transplantation or are receiving renal dialysis at the time of screening
  • History of severe symptomatic hypoglycemia within six months of screening
  • History of diabetic ketoacidosis or other types of metabolic acidosis
  • History of diabetic gastroparesis
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  • History of chronic or acute pancreatitis
  • History of hemochromatosis
  • History or presence of clinically significant cardiovascular disease (including a history of unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, or New York Heart Association Class III or IV congestive heart failure within six months prior to screening)
  • Uncontrolled hypertriglycerides >500 mg/dL
  • History of acute or chronic renal disease; estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73m2
  • Inability to tolerate subcutaneous injections
  • History of allergy, sensitivity or intolerance to peptide products or history of severe hypersensitivity to drugs, foods or other environmental allergens
  • History of coagulation disorders with a potential of causing excessive bleeding or a history of unexplained excessive bleeding
  • Use of warfarin or other anti-coagulation drugs. The use of anti-platelet drugs such as acetylsalicylic acid (daily use) and/or clopidogrel that are prescribed for prevention of cardiovascular events is permitted.
  • Use of systemic glucocorticoids within two weeks of the screening visit, including oral or injectable, or planned use of intermittent systemic corticosteroids during the course of the study. The use of inhaled or topical corticosteroids is permitted.
  • Inadequate venous access
  • Heart rate (HR) <40 bpm or >100 bpm at screening
  • Any clinically significant ECG abnormality at screening (as deemed by the Investigator) including: second or third degree AV block, sick sinus syndrome, atrial fibrillation, presence of other significant dysrhythmias, prolonged QTcF interval >450 msec (the average value for the triplicate ECG at screening and check-In), or history of prolonged QT syndrome
  • Note: The following are ECG findings considered not clinically significant without consulting the Medical Monitor:
  • Mild first-degree atrioventricular block (PR interval <0.23 sec)
  • Right or left axis deviation
  • Incomplete right bundle branch block
  • Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects
  • Reported history of liver disease and/or liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), total bilirubin >2 times the upper limit of normal (ULN) on screening
  • Reported history of clinically significant cerebrovascular or neurological disease including transient ischemic attack, stroke, seizure disorder within one year prior to screening
  • Psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study drug safety
  • Use of weight loss medication at screening or prior weight loss surgery involving the gastrointestinal tract
  • Has active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, or in situ carcinomas of the cervix or prostate) for <5 years
  • History of alcoholism or drug abuse within two years prior to dosing
  • Typical weekly alcohol consumption of ≥ 14 alcoholic drinks. One drink is defined as one can of beer (12 oz, approximately 330 mL 5% alcohol), one glass of wine (5 oz, approximately 140 mL 12% alcohol), or one shot of liquor (1.5 oz, approximately 40 mL 40% alcohol)
  • History of acquired immune deficiency syndrome, hepatitis C, or positive test at screening for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C antibody
  • Patients with a history of blood loss (including blood donation) estimated to be >450 mL within 56 days (or ≥200 mL within 1 month) prior to the Screening Visit
  • Use of any herbal medications or vitamins from the Screening Visit throughout the duration of the study
  • Use of drugs including angiotensin II receptor antagonists (sartans), hydroxymethylglutaryl coenzyme A reductase inhibitors (statins), angiotensin converting enzyme inhibitors (prils) and hypoglycemic drugs (glinides) , other important drugs using OATP1B1/OATP1B3 as main transporters, and other important drugs with NTCP inhibition (appendix 3);
  • Use of another investigational drug or device within 60 days prior to receiving the first dose of study drug in this study, or within five half-lives of the previous investigational drug, whichever is longer
  • Investigational site personnel directly affiliated with this study and/or their immediate families. Immediate family was defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Poor mental function or any other reason to expect subject's difficulty in complying with the requirements of the study
  • History or presence of any medical condition or disease, including known alcohol or drug abuse, which, in the opinion of the Investigator, could have interfered with the conduct of the study or would have put the patient at unacceptable risk

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Repeat-Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of L47 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin

This is a randomized, double-blind, placebo-controlled, repeat-dose study to evaluate the safety, tolerability, PK, and PD of L47 as an add-on treatment to stable metformin therapy in patients with T2DM. Approximately 30 subjects will be randomized into the study at up to two investigational sites. The study includes a screening period of up to 28 days, with a three-day, single-blind, placebo lead-in period; a four-week, double-blind treatment period; and a one-week follow-up period. There will be 2 inpatient stays (Day -3 to 2 and 27 to 29) and daily outpatient visits during treatment period. During the follow-up period, there will be 1 outpatient visit at the end of the study. There will be 3 cohorts of 10 subjects each to be enrolled sequentially. In each cohort, subjects will be randomized in a 4:1 ratio to receive either L47 or placebo subcutaneously. Subjects will monitor fasting capillary glucose (finger sticks or self-monitoring of blood glucose, SMBG) during the lead-in, treatment, and follow-up periods.

Being tested
hepalatide
Keywords
hepalatide, FBG, TG, TC, PK

What participants receive

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

  • hepalatideDrug

    Also called L47

    3 different dosage will be given sequentially to T2D patients

Study groups in NCT04662164
Study groupRoleWhat they receive
placeboPlacebo comparatorcontrol
Receives: Drug: hepalatide
4.2mg hepalatideActive comparatorlow dose
Receives: Drug: hepalatide
6.3mg hepalatideActive comparatormiddle dose
Receives: Drug: hepalatide
8.4mg hepalatideActive comparatorhigh dose
Receives: Drug: hepalatide

What is being measured

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

  1. 24-hour weighed mean glucose (WMG)

    The change from baseline in the 24-hour WMG calculated is as the AUC0-24h divided by 24 using linear trapezoidal method. [Time frame: Baseline (Day -1), to Day 28]

    Measured: 28 days

  2. AEs

    Number and percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), number of subjects discontinuing due to AEs

    Measured: 28 days

Secondary outcomes (1)

  1. fasting plasma glucose

    Change from baseline in fasting plasma glucose (FPG) level [Time frame: Baseline (Day -1), Day28]

    Measured: 28 days

Timeline

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

  1. First posted10 Dec 2020
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Not approved by CFDA

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662164
Sponsor's protocol ID
L47-DM-II-01
Status last verified
Dec 2023
First submitted
3 Dec 2020
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing hepalatide in people with Type 2 Diabetes Patients, run by Shanghai HEP Pharmaceutical Co., Ltd..

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 14 inclusion and 39 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: withdrawn, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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 was withdrawn before enrolling participants, so there are no results.

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?

24-hour weighed mean glucose (WMG) (time frame: 28 days). The study lists 2 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 NCT04662164.

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 8 Dec 2023.

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