Effects of GLP-1 RAs on Human Lactation Outcomes | NCT07720414

NCT07720414

Overview

NCT ID: NCT07720414
Lead Sponsor: University of Colorado, DenverOTHER
Official Title: Effects of GLP-1 RAs on Human Lactation Outcomes
Brief 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.

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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Jun 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 18Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Jayne F Martin Carli, PhDContact
jayne.martincarli@cuanschutz.edu303-724-3981

Similar Studies

Participant Group/Arms

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.

Drug: Injected GLP-1 Receptor Agonists and Dual Agonists