Effects of GLP-1 RAs on Human Lactation Outcomes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07720414
Status
Recruiting
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Conditions

  • Lactation
  • Weight Loss

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Injected GLP-1 Receptor Agonists and Dual Agonists — DRUG
    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 Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
18 participants (estimated)

Arms

  • Arm: 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz School of MedicineAuroraColorado80045-

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University of Colorado Anschutz School of Medicine· Aurora, CO

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