Suspended

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

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What is being tested

Placebo

+ Relamorelin

Drug
Who is being recruted

Diabetes Mellitus+10

+ Digestive System Diseases

+ Endocrine System Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2017
See protocol details

Summary

Principal SponsorAllergan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 29, 2017

Actual date on which the first participant was enrolled.

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Official TitleA 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
NCT03285308
Principal SponsorAllergan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

336 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDigestive System DiseasesEndocrine System DiseasesGastrointestinal DiseasesMetabolic DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesParalysisSigns and SymptomsStomach DiseasesPathological Conditions, Signs and SymptomsGastroparesisGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Diagnosis of Type 1 or Type 2 diabetes mellitus
Meet the per protocol criteria of diabetic gastroparesis
Compliance with diary
Compliance with the per protocol study treatment dosing instructions
5 exclusion criteria prevent from participating
Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1)
Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
History of gastrointestinal disorders that may be similar to gastroparesis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

Group II

Experimental
Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 216 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
Suspended

Digestive Health Specialist of the South East

Dothan, United States
Suspended

Avant Research Associates

Huntsville, United States
Suspended

Synexus Clinical Research US, Inc.

Fountain Hills, United States
Suspended216 Study Centers