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A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Plain-language guide to NCT06973304: phase 3 interventional trial of Teduglutide (GLP-2 analog), 13 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06973304
Phase
phase 3
Status
active, not recruiting
Start
2025-06-26
Completion (planned or actual)
2027-02-10
Participants
13 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Short Bowel Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Teduglutide (GLP-2 analog).

Participants will receive a daily injection of teduglutide under the skin for 24 weeks.

Safety of teduglutide will be checked for 24 weeks after treatment.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 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: Males or females 18 years of age or older at the time of signing the informed consent. Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease). Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent. Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:. Actual PS usage is similar to prescribed PS.

The full record lists 9 inclusion and 25 exclusion criteria; among the exclusions: pregnant or lactating female; use of glucagon-like peptide (glp)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit; use of octreotide, glp-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.

How the Study Was Run

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

Being open-label, the Teduglutide (GLP-2 analog) study did not mask who received what.

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

It started in 2025-06-26 with completion listed for 2027-02-10.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 22 secondary outcomes, for example Absolute Change From Baseline in Weekly PS Volume up to Week 24, Percent Change From Baseline in Weekly PS Volume up to Week 24, Absolute Change From Baseline in Days Per Week of PS up to Week 24, Percent Change From Baseline in Days Per Week of PS up to Week 24, Number of Participants who are able to Completely Wean off of PS support at Week 24 and AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Teduglutide.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 13 people.

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

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.

Our Notes on the Compound

Teduglutide (GLP-2 analog): A GLP-2 analog approved for short bowel syndrome (Gattex/Revestive); it helps the remaining gut absorb more and lowers IV nutrition needs.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.