Trial no.:	PACTR202607841254199	Date of Registration:	14/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

MILK-GDM Semaglutide study

Official scientific title

Phase IV human lactation study to describe the pharmacokinetic of semaglutide in lactating mother-infant pairs in Uganda.

Brief summary describing the background and objectives of the trial

Given the rising burden of gestational diabetes and the potential benefits of breastfeeding, it is critical to evaluate new therapeutics directly in breastfeeding populations, as model-based predictions cannot replace well-designed clinical trials. Semaglutide a Glucagon- Like protein-1 agonists increases insulin sensitivity and decreases insulin resistance. Although limited data suggest minimal semaglutide transfer into breastmilk and low likelihood of infant oral absorption, a dedicated study is still essential to confirm safety and inform evidence-based care. Primary Objective: To define the transfer of semaglutide from mother to breastfed infant during the postpartum period. Secondary Objectives: ▪ To determine the effect of maternal semaglutide on breastmilk composition ▪ To determine the effect of maternal semaglutide on breastmilk volume and breastfeeding practice (frequency, duration) ▪ To determine the effect of maternal semaglutide on infant growth

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

MILKGDM Semaglutide study

Disease(s) or condition(s) being studied

Pregnancy and Childbirth

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

31/05/2026

Actual trial start date

Anticipated date of last follow up

30/11/2026

Actual Last follow-up date

Anticipated target sample size (number of participants)

20

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Single Group	Non-randomised		Allocation Sequence/Code was not concealed	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Semaglutide	Cohort 1: Semaglutide weekly subcutaneous injection, starting at 0.25mg and increasing after 4 weeks to 0.5mg to be maintained for a further 4 weeks. Cohort 2: Semaglutide weekly subcutaneous injection, starting at 0.25mg and increasing after 4 weeks to 0.5mg for another 4 weeks. This will then be increased to 1 mg for another 4 weeks.	Cohort 1: Semaglutide weekly subcutaneous injection, starting at 0.25mg and increasing after 4 weeks to 0.5mg to be maintained for a further 4 weeks. Cohort 2: Semaglutide weekly subcutaneous injection, starting at 0.25mg and increasing after 4 weeks to 0.5mg for another 4 weeks. This will then be increased to 1 mg for another 4 weeks.	Open label, no control group, no blinding. We shall use consecutive sampling, whereby all eligible mothers are assigned consecutively to the first cohort (receiving a maximum dose of 0.5 mg) and the subsequent 10 mothers to the second cohort (receiving a maximum dose of 1.0 mg). We will first enrol the first 10 mothers on the lower dose 0.5mg to monitor the safety before escalating it to 1.0mg. Before titrating each dose, we will have safety labs for the mother and clinical assessment of the infant done the week before, and these will be reviewed by the clinical team. Infant safety questionnaire is administered at every visit	20

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal authorized representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Diagnosed with GDM in the recent pregnancy according to Ugandan guidelines 4. Woman aged 18 years or older 5. Breastfeeding at enrolment or intending to breastfeed during study participation 6. Willing to use adequate contraception for the duration of the study and 8 weeks after semaglutide exposure. 7. No obstetric complication like antepartum hemorrhage, severe postpartum heamorrhage, eclampsia, PET with severe features	Need for insulin therapy ▪ Need for oral hypoglycaemic treatment ▪ Elevation in amylase or lipase beyond normal limits ▪ History of pancreatitis ▪ Liver function tests (AST) or creatinine more than twice the upper limit of normal ▪ Severe physical or mental health condition which would preclude participation ▪ Infant with prematurity (<36 weeks), low birth weight (<2.5 kg), or major congenital abnormality detected at birth ▪ Baseline Body Mass Index <20 kg/m2	Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	60 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

13/02/2026

Infectious Diseases Institute Research ethics committee

Ethics Committee Address
Street address	City	Postal code	Country
IDI,College of Health Sciences Makerere University	kampala	10205	Uganda

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	▪ Steady state concentrations of semaglutide in maternal plasma and breastmilk at pre-dose (0 h), and at 12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h post-dose relative to the 9th subcutaneous dose, at 0.5mg or the 13th subcutaneous dose, at 1.0 mg ▪ Concentrations of semaglutide in infant plasma at pre-dose (0 h), and 24 h, 48 h, 72 h post maternal dose (sample to be obtained via heel prick, as in other MILK studies) ▪ Breastmilk to maternal plasma ratio of semaglutide	Post intervention
Secondary Outcome	Breastmilk composition (fatty acids, proteins and lactose) and pH ▪ Breastmilk volume assessment ▪ Infant growth and development, using standard anthropometric indices – weight, length, head circumference) and simple developmental assessment tools ▪ Maternal perceptions (Treatment Satisfaction Questionnaire) ▪ Trend of maternal HbA1c ▪ Maternal body composition (BMI, lipid profile, hip/waist circ)	pre-dose, during and post intervention

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Infectious Diseases Institute	Mulago NRHC	kampala	P.O. Box	Uganda

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
BILL AND MELINDA GATES foundation	500 Fifth Avenue North Seattle United States	Washington	WA 98109	United States Minor Outlying Islands

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	INFECTIOUS DISEASES INSTITUTE	Mulago Hill Road Makerere University College of Health Sciences Mulago Hospital Complex P.O. Box 22418 Uganda	Kampala	P.O. Box	Uganda	CRO

COLLABORATORS
Name	Street address	City	Postal code	Country
Bode Laboratory	Bode Lab 9500 Gilman Drive Mail	San Diego	92093-07	United States of America

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Catriona Waitt	C.Waitt@liverpool.ac.uk	+256778288217	70 Pembroke Place
City	Postal code	Country	Position/Affiliation
Liverpool	L69 3GF	United Kingdom	Infectious Diseases Institute
Role	Name	Email	Phone	Street address
Public Enquiries	Paul Gonza	pgonza@idi.co.ug	+256754647932	Mulago Hill Road
City	Postal code	Country	Position/Affiliation
Kampala	10205	Uganda	Infectious Diseases Institute
Role	Name	Email	Phone	Street address
Scientific Enquiries	Francis William Ojara	fojara@idi.co.ug	+256770699777	Mulago Hill Road
City	Postal code	Country	Position/Affiliation
Kampala	10205	Uganda	Infectious Diseases Institute

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	The Infectious Diseases Institute (IDI) retains ownership of the data. De-identified datasets may be shared in regulated public repositories with prior IDI notification. Data containing participant identifiers cannot be shared with third parties. Any commercial use requires prior written consent and good-faith licensing negotiations with IDI, which retains full intellectual property rights.	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan	The Data Sharing Agreement will begin immediately upon the signatures of all responsible Parties and UNCST approval and will be terminated within 5 years after receipt of the Data at the Bode laboratory. This Agreement may be extended upon mutual agreement by all Parties. All research data collected from Ugandan participants shall remain available for at least five (5) years after completion of the research study.	The study will ensure data interoperability by applying FAIR data standards. Data will be stored on secure IDI servers with daily backups and password-protected access limited to the data manager and Principal Investigator. A data dictionary will accompany shared datasets. After study completion, data sharing for research and educational purposes will follow IDI and ethical guidelines and occur through approved platforms such as Zenodo.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	07/07/2026	Scientific title has been written in lower case	PHASE IV HUMAN LACTATION STUDY TO DESCRIBE THE PHARMACOKINETICS OF SEMAGLUTIDE IN LACTATING MOTHER-INFANT PAIRS IN UGANDA	Phase IV human lactation study to describe the pharmacokinetic of semaglutide in lactating mother-infant pairs in Uganda.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	07/07/2026	Middle aged 45-64 years has been added since they among eligible participants.	Adult: 18 Year(s)-44 Year(s)	Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	07/07/2026	To clarify when the outcome will be obtained.	Primary Outcome, ▪ Steady state concentrations of semaglutide in maternal plasma and breastmilk at pre-dose (0 h), and at 12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h post-dose relative to the 9th subcutaneous dose, at 0.5mg or the 13th subcutaneous dose, at 1.0 mg ▪ Concentrations of semaglutide in infant plasma at pre-dose (0 h), and 24 h, 48 h, 72 h post maternal dose (sample to be obtained via heel prick, as in other MILK studies) ▪ Breastmilk to maternal plasma ratio of semaglutide , 0 hour, 12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h	Primary Outcome, ▪ Steady state concentrations of semaglutide in maternal plasma and breastmilk at pre-dose (0 h), and at 12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h post-dose relative to the 9th subcutaneous dose, at 0.5mg or the 13th subcutaneous dose, at 1.0 mg ▪ Concentrations of semaglutide in infant plasma at pre-dose (0 h), and 24 h, 48 h, 72 h post maternal dose (sample to be obtained via heel prick, as in other MILK studies) ▪ Breastmilk to maternal plasma ratio of semaglutide , Post intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	07/07/2026	To clarify the time for the secondary outcomes	Secondary Outcome, Breastmilk composition (fatty acids, proteins and lactose) and pH ▪ Breastmilk volume assessment ▪ Infant growth and development, using standard anthropometric indices – weight, length, head circumference) and simple developmental assessment tools ▪ Maternal perceptions (Treatment Satisfaction Questionnaire) ▪ Trend of maternal HbA1c ▪ Maternal body composition (BMI, lipid profile, hip/waist circ), 0 h,12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h	Secondary Outcome, Breastmilk composition (fatty acids, proteins and lactose) and pH ▪ Breastmilk volume assessment ▪ Infant growth and development, using standard anthropometric indices – weight, length, head circumference) and simple developmental assessment tools ▪ Maternal perceptions (Treatment Satisfaction Questionnaire) ▪ Trend of maternal HbA1c ▪ Maternal body composition (BMI, lipid profile, hip/waist circ), pre-dose, during and post intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	07/07/2026	The email and contact have been changed to reflect those of the IDI-REC Chairperson	TRUE, Infectious Diseases Institute Research ethics committee, IDI,College of Health Sciences Makerere University, kampala, 10205, Uganda, , 13 Feb 2026, +256778288217, C.Waitt@liverpool.ac.uk, 41041_38255_4737.pdf	TRUE, Infectious Diseases Institute Research ethics committee, IDI,College of Health Sciences Makerere University, kampala, 10205, Uganda, , 13 Feb 2026, 0704879922, rec@idi.co.ug, 41041_38255_4737.pdf

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