All research
MGF 2022-12-15 ClinicalTrials

Pre-pregnancy weight loss intervention with Tirzepatide aims to reduce offspring overweight and adiposity.

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen

Background

Maternal overweight and obesity before and during pregnancy are significant risk factors for adverse offspring health outcomes, including childhood overweight and adiposity. Current interventions often fall short in achieving sustained pre-conceptional weight loss. This study investigates whether a comprehensive pre-conceptional parental weight loss intervention, including pharmacological support, can effectively mitigate these intergenerational health risks by targeting maternal metabolic health, such as insulin resistance and inflammation, and improving incretin responses.

Study Design

This single-site parallel randomized controlled study will recruit 240 healthy females/couples (prospective mothers with BMI 27-45 kg/m^2, 18-38 years). Participants are randomized 1:1 to either a comprehensive pre-conceptional parental weight loss intervention or a control group, stratified by pre-pregnancy BMI. The intervention targets approximately 10% weight loss over 28 weeks, with adherence to Tirzepatide being a secondary objective. The primary objective is reducing offspring overweight and adiposity at 12 months, along with reducing adverse pregnancy outcomes and neonatal adiposity.

Why It Matters

If successful, this trial could establish a novel pre-conception intervention strategy for women with overweight or obesity, potentially breaking the intergenerational cycle of adiposity. The inclusion of Tirzepatide highlights a pharmacological approach to achieving significant pre-pregnancy weight loss, which could translate into a more effective and accessible protocol for clinicians. This research could redefine guidelines for pre-pregnancy counseling, emphasizing proactive weight management to improve long-term offspring health outcomes, moving beyond traditional gestational weight gain recommendations and potentially impacting public health policy.


tirzepatide weight loss obesity pregnancy childhood obesity pre-conception
Source: clinicaltrials:NCT05621109 · Ingested 2026-05-29 · Digest: gemini-2.5-flash