Proof of Concept Study in Patients With Short Bowel Syndrome

NCT04379856 · Unknown status

Last updated 2026-05-28

This clinical trial tests the safety and tolerability of three different doses of NM002 in patients with short bowel syndrome.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 12 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2020-06 · est. completion 2020-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT04379856 ↗

Description as written by the study sponsor.

This is a Phase I/II. proof of concept, open label, two-dose, dose escalation study of NM-002 in adult patients with SBS who previously responded to exenatide. NM-002 is planned to be administered twice, at up to 3 different dose levels, in up to 3 cohorts, each consisting of 3-4 patients. Doses will be administered on Days 1 and 15 by subcutaneous injection. Patients will be monitored for their usage of parenteral supplementation, and will fill out a daily diary for their symptoms of SBS. Urine output will be measured on a daily basis. Patients will be followed for 6 weeks after the second dose.

Treatments tested

NM-002 Drug

NM-002 is a fusion protein, of which the pharmacological active portion is the glucagon-like peptide-1 (GLP-1) analog domain with the same amino acid sequence as the active pharmaceutical ingredient (exenatide)

Main thing measured	To assess the safety and tolerability of repeated doses of NM002 three different dose levels
Sponsor	9 Meters Biopharma, Inc.
Conditions studied	Short Bowel Syndrome
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04379856 ↗