Assessing the safety and effectiveness of compounded Semaglutide

Published in Obesities
CLINICAL HUB
/

LATEST RESEARCH

Assessing the safety and effectiveness of compounded Semaglutide

A real-world assessment of compounded semaglutide, demonstrating safety and effectiveness, revealing this as a viable alternative during supply shortages

November 21, 2024
7 min read
Published in Obesities

How effective is compounded semaglutide compared to commercial semaglutide?

A new study published in Obesities has provided important insights into the effectiveness and safety of using pharmacy-compounded semaglutide as a component of a real-world digital weight-loss service (DWLS).

The study revealed that both compounded and commercial semaglutide were effective in supporting weight loss, with compounded semaglutide reported to have fewer side effects overall.

Patients using compounded semaglutide lost an average of 9.11% of their baseline weight after four months, compared to 9.87% for patients using commercially manufactured semaglutide, but they reported fewer side effects overall.

Bridging the gap for patient continuity of care

Compounded medications are products that have been prepared by pharmacists. Compounding happens every day in Australia - for medications such as antibiotics, dermatological, paediatric and hormonal treatments and other medications not readily available within Australia. It can also be used to fill medication shortages, or because some patients require a particular non-essential ingredient to be removed from their medication to prevent an allergic reaction.

Compounding is not as common as it once was in Australia since most patient needs are met by commercial pharmaceutical manufacturing. However, due to GLP-1 commercial supply constraints in 2023, compounding semaglutide became necessary to provide patients with the treatment they needed for continuity of care.

Compounding is generally permitted at a threshold level by the Therapeutic Goods Administration (TGA), but more specific rules about compounding safety and quality parameters are set out by the Pharmacy Board of Australia.  In part out of concern that some pharmacies were not in fact following those rules, since October 2024 the TGA no longer permits the compounding of GLP-1 medications by pharmacists who do not have a manufacturing licence.

This research provides crucial evidence on how compounded GLP-1 medications performed in comparison to their commercially available counterparts.

Understanding the results

In the study, data were analysed from 7,683 patients who participated in the Juniper DWLS between June 2023 and May 2024. Patients were divided into two groups: one receiving compounded semaglutide and the other commercial semaglutide, both of which were combined with personalised health coaching via the Juniper app.

The compounded semaglutide used by Juniper patients was prepared in a pharmacy which followed the stringent regulations set out by the Pharmacy Board of Australia. Batches of that medication were also subject to extensive external testing by university laboratories and analysis by pharmacological experts.

To assess the effectiveness of the program, the study measured the percentage of weight loss over a 4-month period, and analysed patient-reported data on side effects, categorising them by severity.

The study revealed that both compounded and commercial semaglutide were effective in supporting weight loss, but with some key differences:

  • In terms of weight loss, patients using compounded semaglutide lost an average of 9.11% of their baseline weight after four months, compared to 9.87% for patients using commercial semaglutide, a difference that was found to be statistically significant.
  • While similar proportions of patients in both groups reached their 5% weight-loss milestone (81.15% vs. 81.70% for compounded and commercial semaglutide, respectively), a higher percentage of patients using commercial semaglutide reached the 10% and 15% weight-loss milestones.
  • When investigating the frequency of side effects, the study found that patients using compounded semaglutide reported statistically fewer side effects overall (71.61%) compared to those on commercial semaglutide (77.40%). The difference was greatest for mild side effects, whereas moderate and severe side effect incidence was similar across both groups, and no life-threatening side effects were reported.

Significance of this research

Compounding is a tried and tested method of solving medicine supply shortages. It’s a highly regulated sector and compounding has recently been used to address shortages of treatments in Australian hospitals.

The findings indicate that - at least when prepared according to stringent safety and quality standards - compounded semaglutide can be a viable alternative to commercial semaglutide when the latter is unavailable, delivering comparable weight-loss outcomes with a similar side effect profile.

Reviewed by

Dr Louis Talay

Medical Research Lead

Eucalyptus

Medical Research Lead | Eucalyptus
Dr Matthew Vickers

Clinical Director

Eucalyptus

Clinical Director | Eucalyptus

Keep your finger on the pulse of the health-tech industry

Subscribe to our newsletter