Healthy VolunteersPhase 1NCT05129891
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
A Phase 1 study testing Semaglutide D, Semaglutide G and Semaglutide H in people with Healthy Volunteers and High Blood Cholesterol Levels, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, High Blood Cholesterol Levels, Type 2 Diabetes
- What is being tested?
- Semaglutide D, Semaglutide G and Semaglutide H
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Nov 2021to 4 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study interventions or related products.
- Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
- Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
In this study, four new tablet versions of two compounds will be investigated.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.
Read more
Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.
The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
- Being tested
- Semaglutide D, Semaglutide G, Semaglutide H, Semaglutide I, NNC0385-0434 B
- 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 DDrug
Tablet given orally
Semaglutide GDrug
Tablet given orally
Semaglutide HDrug
Tablet given orally
Semaglutide IDrug
Tablet given orally
NNC0385-0434 BDrug
Tablet given orally
NNC0385-0434 CDrug
Tablet given orally
NNC0385-0434 DDrug
Tablet given orally
NNC0385-0434 EDrug
Tablet given orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: Oral semaglutide | Experimental | Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days Receives: Drug: Semaglutide D; Drug: Semaglutide G; Drug: Semaglutide H; Drug: Semaglutide I |
| Part B: NNC0385-0434 | Experimental | Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days Receives: Drug: NNC0385-0434 B; Drug: NNC0385-0434 C; Drug: NNC0385-0434 D; Drug: NNC0385-0434 E |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
h * nmol/L
Measured: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
Secondary outcomes (2)
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
nmol/L
Measured: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
hours
Measured: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start3 Nov 2021
- Primary completion26 Feb 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129891
- Sponsor's protocol ID
- NN9501-4821
- Other IDs
- U1111-1266-0672, 2021-001452-34
- Status last verified
- May 2024
- First submitted
- 9 Aug 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05129891
- Acronym / sponsor ID
- NN9501-4821
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 26 Feb 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 22 Nov 2021 (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, four new tablet versions of two compounds will be investigated.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.
Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.
The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Oral semaglutide | Experimental | Drug: Semaglutide D, Drug: Semaglutide G, Drug: Semaglutide H, Drug: Semaglutide IFour different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days |
| Part B: NNC0385-0434 | Experimental | Drug: NNC0385-0434 B, Drug: NNC0385-0434 C, Drug: NNC0385-0434 D, Drug: NNC0385-0434 EFour different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity to study interventions or related products.
- Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
- Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
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 DTablet given orally | Drug | Part A: Oral semaglutide |
| Semaglutide GTablet given orally | Drug | Part A: Oral semaglutide |
| Semaglutide HTablet given orally | Drug | Part A: Oral semaglutide |
| Semaglutide ITablet given orally | Drug | Part A: Oral semaglutide |
| NNC0385-0434 BTablet given orally | Drug | Part B: NNC0385-0434 |
| NNC0385-0434 CTablet given orally | Drug | Part B: NNC0385-0434 |
| NNC0385-0434 DTablet given orally | Drug | Part B: NNC0385-0434 |
| NNC0385-0434 ETablet given orally | Drug | Part B: NNC0385-0434 |
Primary outcome
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
h * nmol/L
2 secondary outcomes
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
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 29 May 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. 1452) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide D, Semaglutide G and Semaglutide H in people with Healthy Volunteers and High Blood Cholesterol Levels, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 5 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Germany. 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?
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose (time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration). 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 29 May 2024.