A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets

NCT04817644 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9924-4669U1111-1253-4467
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)

  nmol\*h/L

  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

  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)

  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)

  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)

  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)

  From 0 to 24 hours after the 10th dosing (day 10)

• Estimated daily infant semaglutide dose

  From 0 to 24 hours after the 10th dosing (day 10)

Study Arms (1)

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.

Drug: Oral semaglutide

Interventions

Oral semaglutide DRUG

Oral semaglutide once daily for a total of 10 days

Oral semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

ICON-Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: September 10, 2021
• Primary Completion: May 26, 2023
• Study Completion: July 3, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)