Complex oral semaglutide lactation study
Case study
Overview
ICON partnered with a global pharmaceutical sponsor to support a lactation study evaluating the concentrations of semaglutide and its absorption enhancer in breast milk following administration of oral semaglutide in healthy lactating women. After another site had experienced prolonged recruitment challenges, ICON was brought into the study as a rescue site to accelerate enrolment and help keep the program on track. Despite the significant demands placed on participants, including a 47-day interruption to breastfeeding and multiple inpatient and outpatient visits, ICON successfully recruited, enrolled, and retained participants through a focused recruitment and engagement strategy delivered from the Salt Lake Clinical Research Unit.
Challenge
After more than a year of recruitment efforts at another site resulted in just two enrolled participants, ICON was brought in as a rescue site to accelerate progress.
The participant burden in this study was substantial. Eligible women were required to discontinue breastfeeding for 47 days while maintaining milk production by regularly pumping and discarding breast milk. The protocol included two separate inpatient stays—a two-day, one-night visit followed approximately one week later by a three-day, two-night visit—as well as multiple follow-up visits through day 47. During the interval between clinic visits, participants were required to self-administer study medication daily at home while continuing their pumping schedule.
In addition, many mothers were unfamiliar with exclusive pumping as their primary method of milk expression. Providing education and support to help participants maintain milk production throughout the study was critical to both recruitment and retention.
Solution
Recognising the need to accelerate enrolment quickly, ICON implemented an intensive recruitment strategy designed to reach the broadest possible pool of potential participants. Targeted advertising campaigns were launched to increase awareness of the study and identify eligible lactating women willing to meet the strict protocol requirements.
To maximise recruitment efficiency, the team complemented outreach efforts with focused pre-screening processes that helped identify motivated and eligible candidates early in the recruitment journey. ICON also provided participants with education and ongoing support related to pumping requirements, helping them navigate the practical challenges associated with temporary breastfeeding interruption.
Drawing on favorable regional demographics in Utah, and a highly engaged study team, ICON rapidly built momentum and established itself as a high-performing rescue site. The team's agility, adaptability, and participant-focused approach ensured potential barriers were addressed proactively throughout the study.
Outcome
-
15
participants screened -
6
participants enrolled -
1
week enrolment period -
100%
completion rate
ICON screened 15 participants and enrolled 6 within just one week, with all enrolled participants successfully completing the study, despite the significant participant burden associated with a 47-day breastfeeding interruption. This exceptional recruitment performance enabled the study to regain momentum and helped keep timelines on track despite previous enrolment challenges.
As a newly onboarded rescue site, ICON rapidly delivered the participant numbers needed to support continued study progress. Through targeted recruitment, proactive participant support, and operational agility, the team mitigated recruitment risk and provided the sponsor with a reliable path forward.
Beyond meeting the immediate study objectives, the successful delivery of the trial established ICON's capabilities in lactation research, creating a strong foundation for future studies within this specialized participant population.