Diabetes Mellitus, Type 2Phase 1NCT05689099
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
A Phase 1 study testing Semaglutide B, 1.34 mg/mL and Semaglutide B, 0.68 mg/mL in people with Diabetes Mellitus, Type 2 and Healthy Participants, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Healthy Participants
- What is being tested?
- Semaglutide B, 1.34 mg/mL and Semaglutide B, 0.68 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol, ibuprofen and acetylsalicylic acid, within 14 days prior to the day of screening
- Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits)
- Positive alcohol test at screening
Show all 9Show fewer
- Abuse or intake of drugs, defined as any of the below:
- Known or suspected drug or chemical substance abuse within 1 year before screening
- Positive drug of abuse test at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official title: A Study to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.34 mg/mL
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
- Conditions
- Diabetes Mellitus, Type 2, Healthy Participants
- Being tested
- Semaglutide B, 1.34 mg/mL, Semaglutide B, 0.68 mg/mL
- 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.
Semaglutide B, 1.34 mg/mLDrug
Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Semaglutide B, 0.68 mg/mLDrug
Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2. Receives: Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide B, 0.68 mg/mL |
| Sequence B | Experimental | Participants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2. Receives: Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide B, 0.68 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
Measured in nanomoles per liter (nmol/L).
Measured: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start17 Jan 2023
- Primary completion30 May 2023
- Study completion30 May 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.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689099
- Sponsor's protocol ID
- NN9535-7560
- Other IDs
- U1111-1280-1368
- Status last verified
- Oct 2024
- First submitted
- 9 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.34 mg/mL
- ClinicalTrials.gov ID
- NCT05689099
- Acronym / sponsor ID
- NN9535-7560
- Conditions
- Diabetes Mellitus, Type 2, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 Jan 2023 (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.
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Semaglutide B, 1.34 mg/mL, Drug: Semaglutide B, 0.68 mg/mLParticipants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2. |
| Sequence B | Experimental | Drug: Semaglutide B, 1.34 mg/mL, Drug: Semaglutide B, 0.68 mg/mLParticipants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female
- Aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive)
Key exclusion criteria (9 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol, ibuprofen and acetylsalicylic acid, within 14 days prior to the day of screening
- Abuse or intake of alcohol, defined as any of the below:
- Abuse or intake of drugs, defined as any of the below:
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 |
|---|---|---|
| Semaglutide B, 1.34 mg/mLParticipants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously. | Drug | Sequence A, Sequence B |
| Semaglutide B, 0.68 mg/mLParticipants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously. | Drug | Sequence A, Sequence B |
Primary outcome
AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in hours*nanomoles per liter (h*nmol/L).
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in nanomoles per liter (nmol/L).
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 15 Oct 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
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 Semaglutide B, 1.34 mg/mL and Semaglutide B, 0.68 mg/mL in people with Diabetes Mellitus, Type 2 and Healthy Participants, run by Novo Nordisk A/S 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 3 inclusion and 9 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 15 Oct 2024. 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. 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?
AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg (time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg). 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?
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 15 Oct 2024.