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GLP-2 (Teduglutide) Phase 2 Trial for Environmental Enteric Dysfunction in Undernourished Women, Dhaka

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Summary

The NIH ClinicalTrials.gov registry published a Phase 2 clinical trial (NCT07537686) evaluating teduglutide (a GLP-2 analog) for treatment of environmental enteric dysfunction (EED) in 40 undernourished women aged 18-35 in Dhaka, Bangladesh. The randomized study will assess whether 30 days of daily subcutaneous teduglutide injections improve intestinal damage (via biopsy) and gut inflammation markers. icddr,b (Bangladesh) is a collaborating institution.

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What changed

The NIH ClinicalTrials.gov registry added a Phase 2 interventional study (NCT07537686) testing teduglutide 0.05 mg daily subcutaneous injections over 30 days for environmental enteric dysfunction in undernourished women. Participants receive nutritional support and undergo upper GI endoscopy for EED confirmation at baseline and after treatment. The trial is conducted in urban slums of Dhaka, Bangladesh with icddr,b as a collaborating institution.

Affected parties including clinical investigators, pharmaceutical companies, and healthcare providers should note this trial advances the regulatory pathway for teduglutide in EED indications. The study targets a population with significant unmet medical need—undernourished women with histology-confirmed EED—and may inform future larger pivotal trials and potential regulatory submissions.

Archived snapshot

Apr 19, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)

Phase 2 NCT07537686 Kind: PHASE2 Apr 17, 2026

Abstract

The goal of this clinical trial is to learn whether teduglutide, a medicine that helps the intestine heal, can improve environmental enteric dysfunction in undernourished women aged 18 to 35 years living in urban slums of Dhaka.

Environmental enteric dysfunction is a long-lasting condition of the small intestine. It causes inflammation and poor absorption of nutrients. Many people with this condition do not have clear symptoms, but it can make undernutrition worse. At present, there is no proven treatment for this condition.

The main questions this study aims to answer are:

  • Does taking teduglutide for 30 days improve damage to the small intestine, as seen on intestinal biopsy?
  • Does teduglutide improve blood and stool markers related to gut inflammation and nutrient absorption?

Participants will:

  • Receive nutritional support at the start of the study
  • Undergo an upper gastrointestinal endoscopy to confirm environmental enteric dysfunction
  • Receive a daily injection of teduglutide under the skin for 30 days
  • Undergo repeat endoscopy and laboratory tests after treatment to assess changes in gut health The results of this study will help researchers understand whether teduglutide may be a useful treatment for environmental enteric dysfunction in undernourished adult women and will guide future, larger studies.

Conditions: Environmental Enteric Dysfunction

Interventions: Teduglutide 0.05 dose

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537686

Who this affects

Applies to
Clinical investigators Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trials Drug research and development Healthcare research
Geographic scope
BD BD

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Public Health Healthcare

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