Diabetes Mellitus, Type 2Phase 1NCT04817644
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
A Phase 1 study testing Oral semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2021to 3 Jul 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. Using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator.
- Agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "End of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and SNAC.
- The breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by Novo Nordisk) prior to screening.
- Age above or equal to 18 years at the time of agreement to take part.
- Body mass index (BMI) between 20.0 and 32.4 kg/m^2 (both inclusive).
Who cannot join
- Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by the subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records).
- Presence or history (as declared by the subject or reported in the medical records) of malignant neoplasm within 5 years prior to the day of screening (basal or squamous cell skin cancer, or any carcinoma in-situ is allowed).
- Presence or history (as declared by the subject or reported in the medical records) of pancreatitis (acute or chronic).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON-Salt Lake City
Salt Lake City, Utah, 84124
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral semaglutide
- 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.
Oral semaglutideDrug
Oral semaglutide once daily for a total of 10 days
| Study group | Role | What they receive |
|---|---|---|
| Oral semaglutide | Experimental | All participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days. Receives: Drug: Oral semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
nmol*h/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Secondary outcomes (63)
Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk)
nmol/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk)
nmol/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk)
nmol/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk)
Hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant semaglutide dose
mg/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Relative daily infant semaglutide dose
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Relative daily infant SNAC dose
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E494 dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E506 dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E1245 dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E1246 dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1247 milk concentration after the 10th dosing (tmax,E1247,D10,milk)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E1247 dose
ng/kg/day
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,plasma)
nmol*h/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,plasma)
nmol/L
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (tmax,sema,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC plasma concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC plasma concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E494 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (tmax,E494,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E506 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (tmax,E506,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (tmax,E1245,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1246 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (tmax,E1246,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1247 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,plasma)
ng*h/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,plasma)
ng/mL
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (tmax,E1247,D10,plasma)
hours
Measured: From 0 to 24 hours after the 10th dosing (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Sep 2021
- Primary completion26 May 2023
- Study completion3 Jul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT04817644
- Sponsor's protocol ID
- NN9924-4669
- Other IDs
- U1111-1253-4467
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2021
- Last updated
- 11 Mar 2025
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females
- ClinicalTrials.gov ID
- NCT04817644
- Acronym / sponsor ID
- NN9924-4669
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 26 Mar 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.
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral semaglutide | Experimental | Drug: Oral semaglutideAll participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. Using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator.
- Agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "End of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and SNAC.
- The breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by Novo Nordisk) prior to screening.
- Age above or equal to 18 years at the time of agreement to take part.
- Body mass index (BMI) between 20.0 and 32.4 kg/m^2 (both inclusive).
Key exclusion criteria (7 listed)
- Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by the subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records).
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 |
|---|---|---|
| Oral semaglutideOral semaglutide once daily for a total of 10 days | Drug | Oral semaglutide |
Primary outcome
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
nmol*h/L
Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
ng*h/mL
63 secondary outcomes
Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant semaglutide dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Relative daily infant semaglutide dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Relative daily infant SNAC dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E494 dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E506 dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E1245 dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Estimated daily infant SNAC metabolite E1246 dose
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk)
Time frame: From 0 to 24 hours after the 10th dosing (day 10)
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 11 Mar 2025.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites 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 5 inclusion and 7 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 11 Mar 2025. 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 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?
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk) (time frame: From 0 to 24 hours after the 10th dosing (day 10)). 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 11 Mar 2025.