LactationNCT07720414
Effects of GLP-1 RAs on Human Lactation Outcomes
An observational study of Lactation and Weight Loss, run by University of Colorado, Denver at 1 site in United States.
Trial summary
There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation, Weight Loss
- What is being tested?
- Injected GLP-1 Receptor Agonists and Dual Agonists
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Breastfeeding mothers willing to attend study study visits in Aurora, CO.
Who may be able to join
- Breastfeeding mothers of single or multiple infants.
- Milk removal at least 4x daily
- Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)
- Access to a breastpump, if needed for maintaining breastfeeding behaviors.
- Willingness to provide 1-3 oz of breastmilk per study visit.
- Willingness to track and report body weight daily.
- Willingness to maintain breastfeeding behaviors for the duration of the study.
Who cannot join
- Currently taking GLP-1 RA medication or other weight loss medication
- Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045
About this study
There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk.
The main questions the study will address are:
Read more
- Does GLP-1 RA-induced weight loss increase or decrease breastmilk production?
- Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content?
Researchers will assess milk production rates before and after mothers begin taking injected GLP-1 RA medications to decrease their body weight. Weight loss will be confirmed with 7-day body weight averages.
Participants will:
- Weigh themselves and report measurements daily.
- Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each).
During each visit, participants will:
- Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production.
- Provide 1-3 oz of milk for further study.
- Answer questions about breastfeeding patterns.
- Conditions
- Lactation, Weight Loss
- Being tested
- Injected GLP-1 Receptor Agonists and Dual Agonists
- Keywords
- Breastmilk production, Breastmilk composition, GLP-1, Weight Loss
- Medical subject headings
- Breast Feeding, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injected GLP-1 Receptor Agonists and Dual AgonistsDrug
Participants are prescribed this medication by their care provider(s) as part of their postnatal clinical care, including but not limited to semaglutide and tirzepatide. The investigators do not provide, manage, or assign the medication.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding mothers prescribed GLP-1 RA therapies | Breastfeeding mothers who have been prescribed, but have not started, an injected GLP-1RA (these patients have an indication for GLP-1 RA treatment (BMI ≥27 kg/m2 with at least one comorbidity (prediabetes, diabetes, metabolic syndrome, obstructive sleep apnea, hypertension, dyslipidemia, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatohepatitis, atrial fibrillation, venous thromboembolic disease, osteoarthritis, polyendocrine metabolic ovarian syndrome), or BMI ≥30 kg/m2)) and who are committed to sustaining breastfeeding habits (frequency and volume of milk removal) for the duration of the study period. Receives: Drug: Injected GLP-1 Receptor Agonists and Dual Agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hourly milk production rate
Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.
Measured: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.
Milk macronutrient composition
Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.
Measured: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720414
- Sponsor's protocol ID
- 26-1234
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and leftover biological samples may be deposited into public or restricted-access data banks, or distributed directly to external researchers for future study without additional participant consent. Data and specimens will be stripped of names and direct identifiers prior to sharing or repository submission. Recipients of these assets may include researchers working at other universities, government agencies, or private industry. Future research utilizing this data may focus on obesity, weight loss treatments, or other related medical conditions. While data are de-identified to protect privacy, absolute protection against re-identification cannot be guaranteed, and broad data sharing may involve unknown risks.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 RAs on Human Lactation Outcomes
- ClinicalTrials.gov ID
- NCT07720414
- Acronym / sponsor ID
- 26-1234
- Conditions
- Lactation, Weight Loss
- Keywords
- Breastmilk production, Breastmilk composition, GLP-1, Weight Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jul 2026 (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.
There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk.
The main questions the study will address are:
- Does GLP-1 RA-induced weight loss increase or decrease breastmilk production?
- Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content?
Researchers will assess milk production rates before and after mothers begin taking injected GLP-1 RA medications to decrease their body weight. Weight loss will be confirmed with 7-day body weight averages.
Participants will:
- Weigh themselves and report measurements daily.
- Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each).
During each visit, participants will:
- Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production.
- Provide 1-3 oz of milk for further study.
- Answer questions about breastfeeding patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding mothers prescribed GLP-1 RA therapies | – | Drug: Injected GLP-1 Receptor Agonists and Dual AgonistsBreastfeeding mothers who have been prescribed, but have not started, an injected GLP-1RA (these patients have an indication for GLP-1 RA treatment (BMI ≥27 kg/m2 with at least one comorbidity (prediabetes, diabetes, metabolic syndrome, obstructive sleep apnea, hypertension, dyslipidemia, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatohepatitis, atrial fibrillation, venous thromboembolic disease, osteoarthritis, polyendocrine metabolic ovarian syndrome), or BMI ≥30 kg/m2)) and who are committed to sustaining breastfeeding habits (frequency and volume of milk removal) for the duration of the study period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breastfeeding mothers willing to attend study study visits in Aurora, CO.
Key inclusion criteria (7 listed)
- Breastfeeding mothers of single or multiple infants.
- Milk removal at least 4x daily
- Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)
- Access to a breastpump, if needed for maintaining breastfeeding behaviors.
- Willingness to provide 1-3 oz of breastmilk per study visit.
Key exclusion criteria (2 listed)
- Currently taking GLP-1 RA medication or other weight loss medication
- Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.
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 |
|---|---|---|
| Injected GLP-1 Receptor Agonists and Dual AgonistsParticipants are prescribed this medication by their care provider(s) as part of their postnatal clinical care, including but not limited to semaglutide and tirzepatide. The investigators do not provide, manage, or assign the medication. | Drug | Breastfeeding mothers prescribed GLP-1 RA therapies |
Primary outcome
Hourly milk production rate
Time frame: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.
Milk production rate (in grams per hour) will be assessed using a standardized milk expression protocol.
Milk macronutrient composition
Time frame: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.
Milk macronutrient composition will be assessed using the Miris Human Milk Analyzer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and leftover biological samples may be deposited into public or restricted-access data banks, or distributed directly to external researchers for future study without additional participant consent. Data and specimens will be stripped of names and direct identifiers prior to sharing or repository submission. Recipients of these assets may include researchers working at other universities, government agencies, or private industry. Future research utilizing this data may focus on obesity, weight loss treatments, or other related medical conditions. While data are de-identified to protect privacy, absolute protection against re-identification cannot be guaranteed, and broad data sharing may involve unknown risks.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactation and Weight Loss, run by University of Colorado, Denver 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 2 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayne F Martin Carli, PhD (303-724-3981, jayne.martincarli@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hourly milk production rate (time frame: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.). 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 22 Jul 2026.