Diabetes Mellitus, Type 2Phase 1NCT05328726
Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects
A Phase 1 study testing GZR-18 in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 1 site in United States.
Trial summary
Single ascending dose first time in human study for GZR18 in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GZR-18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2022to 9 Mar 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign and date informed consent prior to any study-related activities being performed
- Be considered healthy in the opinion of the PI or qualified designee and have no clinically significant abnormal laboratory values at screening
- Male
- Aged 18 to 60 years, inclusive, at the time of signing the informed consent. Note: if the study is to be conducted at a clinical site located in Lincoln, Nebraska, the lower age limit will be 19 years of age
- Have a BMI between 20.0 to 35.0 kg/m2, inclusive, at Screening or check-in prior to dosing
- Have a normal renal function as defined by estimated glomerular filtration rate (eGFR) > 90 mL/min/1.73m2 at Screening or check-in prior to dosing
- Be able to understand and comply with protocol requirements, instructions, and any protocol-stated restrictions
Who cannot join
- The Investigator or qualified designee considers the subject unfit for the study, based on medical interview, physical examination, or laboratory results. Individuals must be free from clinically significant illness or disease, as determined by the PI or qualified designee, with no clinically significant abnormality identified on the medical or laboratory evaluations, including 12-lead ECG
- Positive hepatitis-B surface antigen, positive hepatitis-C, or positive HIV test
- History of cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to screening
- Personal or family history of medullary cell carcinoma or multiple endocrine neoplasia syndrome type 2
- History of inadequately controlled thyroid disease, as reflected by an abnormal thyroid stimulating hormone test or free T4
- History of gastrointestinal disease that could affect fat or bile acid ab-sorption, including inflammatory bowel disease, chronic diarrhea, Crohn's disease, or malabsorption syndromes within the past year. Note: Subjects with a cholecystectomy more than 1 year prior to screening can be considered for inclusion in the study
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- History of gastrointestinal surgical intervention for obesity
- History of chronic or acute pancreatitis
- History of significant drug or other allergy or hypersensitivity that, in the opinion of the Investigator or qualified designee, contraindicates the subject's participation in the study
- History of alcohol abuse, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is defined as equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine
- Unwilling to abstain from alcohol from 24 hours prior to the start of dosing until discharge from the clinic
- Smoked or used tobacco- or nicotine-containing products within the previous 6 months prior to Screening
- Treatment with an investigational drug or participated in any other interventional clinical study during the previous 30 days or within 5 half-lives after the last dose of the investigational drug, whichever is longer. Note: 30-day/5-half-life washout is defined as last dose of investigational drug in the previous study until the first screening visit in the current study
- Unwilling to refrain from the use of illicit drugs and unwilling to ad-here to other protocol-stated restrictions while participating in the study
- Unwilling to abstain from caffeine- or xanthine-containing products from 24 hours prior to dosing until discharge from the clinic
- A positive drug and alcohol screen at screening or check-in prior to dosing
- A positive pre-study urine cotinine screen indicating use of tobacco/nicotine-containing products at Screening or check-in prior to dosing
- Use of prescription or non-prescription drugs, vitamins, or dietary/herbal supplements within 1 week prior to the dosing of study drug through the final follow-up visit
- Donated 500 mL or greater of blood within 56 days prior to dosing or plans on donating blood in the 30 days following completion of the study
- Have any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Sequential, Single, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of Subcutaneous Injections of GZR18 in Healthy Subjects
Single ascending dose first time in human study for GZR18 in healthy subjects
Read the detailed description
A double-blind, randomized, placebo-controlled, sequential, single, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of subcutaneous injections of GZR18 in healthy subjects
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GZR-18, 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.
GZR-18Drug
As previously described in Arms
PlaceboOther
Also called Placebo Control
Placebo will be dosed in an identical manner to active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Drug:GZR-18 administered via subcutaneous injection | Experimental | For Assigned Interventions: GZR-18 administered once via subcutaneous injection at doses of 1.0 ug/kg, 5.0 ug/kg, 10.0 ug/kg, 20.0 ug/kg, 30.0 ug/kg, 40.0 ug/kg \& 50.0 ug/kg Receives: Drug: GZR-18 |
| Placebo control | Placebo comparator | Commercially obtained sterile, normal saline for injection will be used as the matching placebo. Placebo will be dosed in an identical manner to active study drug. The volume of placebo will be calculated according to body weight using active drug dose for volume calculation in order to maintain the study blind. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
The primary outcome for this study is Dose Limiting Toxicity, which is the composite of any SAE, any pancreatitis(as measured by amylase) or renal dysfunction (as measured by serum creatinine)
Measured: Up to 31 days
Secondary outcomes (2)
Maximum Plasma Concentration
Cmax
Measured: Up to 720 hours
Glycosylated Hemoglobin
HbA1c
Measured: Up to 720 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start8 Mar 2022
- Primary completion9 Feb 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded, randomized, placebo-controlled, sequential, dose-escalating, single-dose study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Lazaroff, MSN, Study director, Gan and Lee Pharmaceuticals, USA Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328726
- Sponsor's protocol ID
- GL-GLP-1012
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Sequential, Single, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of Subcutaneous Injections of GZR18 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05328726
- Acronym / sponsor ID
- GL-GLP-1012
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 14 Apr 2022 (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.
Single ascending dose first time in human study for GZR18 in healthy subjects
Detailed description
A double-blind, randomized, placebo-controlled, sequential, single, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of subcutaneous injections of GZR18 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blinded, randomized, placebo-controlled, sequential, dose-escalating, single-dose study.
| Arm | Type | Receives |
|---|---|---|
| Drug:GZR-18 administered via subcutaneous injection | Experimental | Drug: GZR-18For Assigned Interventions: GZR-18 administered once via subcutaneous injection at doses of 1.0 ug/kg, 5.0 ug/kg, 10.0 ug/kg, 20.0 ug/kg, 30.0 ug/kg, 40.0 ug/kg \& 50.0 ug/kg |
| Placebo control | Placebo comparator | Other: PlaceboCommercially obtained sterile, normal saline for injection will be used as the matching placebo. Placebo will be dosed in an identical manner to active study drug. The volume of placebo will be calculated according to body weight using active drug dose for volume calculation in order to maintain the study blind. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sign and date informed consent prior to any study-related activities being performed
- Be considered healthy in the opinion of the PI or qualified designee and have no clinically significant abnormal laboratory values at screening
- Male
- Aged 18 to 60 years, inclusive, at the time of signing the informed consent. Note: if the study is to be conducted at a clinical site located in Lincoln, Nebraska, the lower age limit will be 19 years of age
- Have a BMI between 20.0 to 35.0 kg/m2, inclusive, at Screening or check-in prior to dosing
Key exclusion criteria (20 listed)
- The Investigator or qualified designee considers the subject unfit for the study, based on medical interview, physical examination, or laboratory results. Individuals must be free from clinically significant illness or disease, as determined by the PI or qualified designee, with no clinically significant abnormality identified on the medical or laboratory evaluations, including 12-lead ECG
- Positive hepatitis-B surface antigen, positive hepatitis-C, or positive HIV test
- History of cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to screening
- Personal or family history of medullary cell carcinoma or multiple endocrine neoplasia syndrome type 2
- History of inadequately controlled thyroid disease, as reflected by an abnormal thyroid stimulating hormone test or free T4
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 |
|---|---|---|
| GZR-18As previously described in Arms | Drug | Drug:GZR-18 administered via subcutaneous injection |
| PlaceboAlso: Placebo ControlPlacebo will be dosed in an identical manner to active study drug. | Other | Placebo control |
Primary outcome
Dose limiting toxicity
Time frame: Up to 31 days
The primary outcome for this study is Dose Limiting Toxicity, which is the composite of any SAE, any pancreatitis(as measured by amylase) or renal dysfunction (as measured by serum creatinine)
2 secondary outcomes
Maximum Plasma Concentration
Time frame: Up to 720 hours
Glycosylated Hemoglobin
Time frame: Up to 720 hours
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 23 Mar 2023.
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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.
Kimberly Lazaroff, MSN study director
Gan and Lee Pharmaceuticals, USA Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR-18 in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 1 site in United States.
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 7 inclusion and 20 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 23 Mar 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 United States. 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 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?
Dose limiting toxicity (time frame: Up to 31 days). 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 23 Mar 2023.