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Diabetes Mellitus, Type 2Phase 1NCT03745885

A Study of the Efficacy and Safety of Supaglutide in Healthy Participants

A Phase 1 study testing Supaglutide injection in people with Diabetes Mellitus, Type 2, run by Shanghai Yinnuo Pharmaceutical Technology 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 study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese healthy subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Supaglutide injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
4 Dec 2018to 13 Dec 2019
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects between 18 and 45 years old（inclusive）.
  • Body mass index（BMI）is between 18 and 28 kg/m2 (inclusive). The weight of male subjects should not be less than 50 kg, and female subjects should not be less than 45 kg.
  • The female participant with reproductive potential, will be required a negative pregnancy test before trial, maintaining non-pregnancy during the whole study period and contraception 3 months after formal injection.
  • Participants must sign the informed consent.

Who cannot join

  • Have a history of allergic reaction or hypersensitivity to the study drugs, or who develop allergic reaction.
  • Have an evidence of Fasting blood-glucose greater than (>) 6.0 mmol/L or less than (<) 3.9 mmol/L, or hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%);
  • Have evidence of Sitting Blood ( take a break for five minutes) , systolic pressure exceeds the range of 90 to 140 mmHg, or diastolic pressure exceeds the range of 50 to 90 mmHg, or Heart Rate exceeds the range of 50 bpm to100 bpm (including critical value)
  • Have an evidence of ECG abnormalities including QTc >450 msec or QRS complex >120 msec. If QT Corrected >450 msec; or QRS >120msec, subject should Repeat the ECG measurements twice and use the average of the QTc or QRS values measured to determine whether the subjects are eligible.
  • Have an evidence of physical examination, vital sign, laboratory examination or electrocardiographic examination that investigator think can affect this trial;
  • Have an individual or a family history of thyroid C-cell tumors/ carcinoma or with a history of thyroid dysfunction, thyroid hormone abnormalities or thyroid-related hormones exceeded the normal range;
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  • Have a history of significant illness or medical disorders, including acute or chronic pancreatitis, cardiovascular disease, renal disorder, hematological disease，hepatic or gastrointestinal disease, neurological or psychiatric disease, metabolic disorder, or other diseases that may affect the absorption, distribution, metabolism or excretion of drugs, such as active gastrointestinal ulcers or bleeding, gastrointestinal surgery(except appendectomy).
  • Have a history of major surgery within 4 weeks or major minor surgery during the whole study period;
  • Have a history of smoking or the use of nicotine products or electronic cigarettes, abusing alcohol or abusing drug within 3 months;
  • Have a presence of prescription or non-prescription drugs, including Chinese Traditional and Herbal Drugs within 2 weeks; Previous use of glucagon-like peptide-1 analogue or another intestinal insulin, or any unknown cause of infections.
  • Have a presence of any food or drink containing caffeine or xanthine within 48 hours before administration.
  • Have a history of a New Chemical Entity clinical study within the previous 3 months.
  • Have a presence of pregnancy or lactation.
  • Have a presence of positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV), or human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.
  • Have a history of blood donation or loss more than 400 ml (including in the frame of a clinical study) within 3 months before administration;

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study the Efficacy and Safety of Supaglutide in Chinese Healthy Subjects

This study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese healthy subjects.

Being tested
Supaglutide injection, Placebo
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.

  • Supaglutide injectionDrug

    Also called Diabegone

    Administered SC in the Supaglutide arms.

  • PlaceboDrug

    Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.

Study groups in NCT03745885
Study groupRoleWhat they receive
0.15mg Supaglutide or placeboExperimental0.15 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants
Receives: Drug: Supaglutide injection; Drug: Placebo
0.375mg Supaglutide or placeboExperimental0.375 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants
Receives: Drug: Supaglutide injection; Drug: Placebo
0.75mg Supaglutide or placeboExperimental0.75 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants
Receives: Drug: Supaglutide injection; Drug: Placebo
1.5mg Supaglutide or placeboExperimental1.5 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants
Receives: Drug: Supaglutide injection; Drug: Placebo
3.0mg Supaglutide or placeboExperimental3.0 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously（SC） to healthy participants
Receives: Drug: Supaglutide injection; Drug: Placebo

What is being measured

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

  1. Pharmacokinetic：Cmax of Supaglutide

    Maximum Concentration(Cmax) of Supaglutide

    Measured: baseline and up to 29 days after formal dose

  2. Pharmacokinetic: Tmax of Supaglutide

    Time to maximum plasma concentration (Tmax)

    Measured: baseline and up to 29 days after formal dose

  3. Pharmacokinetic: AUC0-t of Supaglutide

    Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)

    Measured: baseline and up to 29 days after formal dose

  4. Pharmacokinetic: t½ of Supaglutide

    Terminal elimination half-life in plasma (t½)

    Measured: baseline and up to 29 days after formal dose

Timeline

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

  1. First posted19 Nov 2018
  2. Study start4 Dec 2018
  3. Primary completion10 Jun 2019
  4. Study completion13 Dec 2019

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745885
Sponsor's protocol ID
YN011A
Status last verified
Sep 2021
First submitted
16 Nov 2018
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17.

    PubMed 39961992

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Supaglutide injection in people with Diabetes Mellitus, Type 2, run by Shanghai Yinnuo Pharmaceutical Technology 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 4 inclusion and 15 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 Sep 2021. 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?

Pharmacokinetic：Cmax of Supaglutide (time frame: baseline and up to 29 days after formal dose). 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 NCT03745885, which also lists 1 linked publication.

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 Sep 2021.

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