Semaglutide in CFRD

What Was Tested

The trial (phase 2, phase 3) is built around Semaglutide.

It had 1 arm (groups): Single Arm (other).

The registry classes the interventions as drug.

More on the Plan

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial.

In this study, the researchers will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD.

Specific Aim 1: Collect pilot data on the safety and feasibility of weekly semaglutide therapy in overweight and obese patients with CFRD to support a future larger randomized controlled trial.

Specific Aim 2: Collect preliminary data to examine the impact of semaglutide therapy on insulin secretion, glucagon and glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM) and HbA1c.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult subjects 18 years or older with CFRD and on insulin treatment. BMI \>26 kg/m2. Diagnosis of pancreatic insufficiency (based on treatment with pancreatic enzyme replacement therapy).

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (men2); acute pulmonary exacerbation requiring iv antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures; gastrointestinal(gi) symptom exacerbation defined by current nausea/vomiting or diarrhea at the baseline assessment.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-10-16 with completion listed for 2024-12-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Weight (time frame: 12 weeks). BMI (kg/m2) (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example CGM % Time in Target TIR) and A1c.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Semaglutide in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.