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Effects of GLP-1 RAs on Human Lactation Outcomes

Effects of GLP-1 RAs on Human Lactation Outcomes

Recruiting
Female
Phase N/A

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Overview

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.

Eligibility

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 details
    Lactation
    Weight Loss

NCT07720414

University of Colorado, Denver

25 July 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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