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NCT07720414·Not applicable·OBSERVATIONAL

Effects of GLP-1 RAs on Human Lactation Outcomes

TirzepatideSemaglutideWeight lossRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

18

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Injected GLP-1 Receptor Agonists and Dual Agonists

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.

Timeline

From registration to results.

  1. First posted

    Jul 22, 2026

  2. Study start

    Jul 2026

  3. Primary completion

    Jun 2028

  4. Study completion

    Jun 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 22, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Colorado Anschutz School of Medicine

Aurora, Colorado, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTirzepatide trial dashboard →DatabaseTirzepatide database entry →ResearchTirzepatide research guide →TrialsSemaglutide trial dashboard →DatabaseSemaglutide database entry →ResearchSemaglutide research guide →