Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03383146) enrolled 450 people in total — 148 in the placebo group and 302 in the relamorelin 10 μg group — though not all of them completed the study. The trial was looking at a condition called diabetic gastroparesis, where the stomach empties too slowly in people with diabetes. Participants rated four symptoms daily — nausea, stomach pain, feeling overly full after eating, and bloating — on a scale of 0 to 40, where higher numbers mean worse symptoms. The trial measured how much those scores changed over 12 weeks and 52 weeks. The reported data shows that at the start of the study, both groups had similar average symptom scores (around 20 out of 40). After 12 weeks, the placebo group's score had dropped by an average of 7.1 points, while the relamorelin group's score had dropped by an average of 6.5 points. After 52 weeks, the placebo group's score had dropped by an average of 10.7 points, while the relamorelin group's score had dropped by an average of 8.6 points. In both cases, a drop in score means symptoms were reported as less severe than at the start. The reported data also shows that 105 out of 145 placebo participants and 221 out of 299 relamorelin participants experienced at least one adverse event (an unwanted medical occurrence during the study period). No participants in either group were reported to have clinically meaningful changes in vital signs, and 2 participants in each group had clinically significant abnormal heart-trace (ECG) results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Gastroparesis Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
If you were in a previous related study (Rollover Participants):
- You took part in one of two specific earlier studies (NCT03285308 or NCT03426345) and met most of the requirements during that study's initial period, but were not selected for the treatment phase because your symptom scores or vomiting patterns fell within certain ranges (confirm with trial site)
If you are joining fresh (De Novo Participants):
- You have had Type 1 or Type 2 diabetes for at least 5 years, with reasonably controlled blood sugar and a specific blood sugar marker (HbA1c) at or below 11%
- You have had ongoing stomach-related symptoms for at least 3 months before the screening visit, with nausea being one of them, along with possible symptoms like bloating, vomiting, or feeling full quickly — suggesting a condition called gastroparesis (slow stomach emptying)
- You were able to consistently record your symptoms on a handheld electronic device during a 2-week lead-in period
- You were able to consistently give yourself two injections under the skin each day during the lead-in period
- Your average daily symptom score over the 2-week lead-in period was high enough to meet the study's minimum threshold (confirm with trial site for exact score details)
Who may not be able to join:
For everyone:
- You have a known allergy or sensitivity to the study drug or any of its ingredients, including mannitol or phenol
If you are joining fresh (De Novo Participants):
- You have had an eating disorder such as anorexia nervosa, binge-eating, or bulimia within the past 5 years
- You have a history of problems absorbing nutrients from food or your pancreas not producing enough digestive enzymes
- You have a history of excessive belching disorders or other conditions causing nausea and vomiting unrelated to gastroparesis
- You had a stomach or small intestine ulcer within 3 months before the screening visit
- You have been diagnosed with cancer in the past 3 years, unless it was a type of treatable skin cancer or early-stage cervical cancer that has been fully treated
- You are currently being fed through a tube or IV line rather than eating normally
- You have taken certain stomach-motility medications (such as metoclopramide, domperidone, erythromycin, or similar drugs) within at least 10 days before the lead-in period started
- You are currently taking or expect to take opioid pain medicines during the study
- You have been taking a type of diabetes medication called a GLP-1 agonist within 6 weeks before the lead-in period started
- You have had botulinum toxin (Botox) injected into your stomach's outlet valve within 6 months of screening
- You have had stomach surgery in the past, such as weight-loss surgery, stomach pacemaker placement, or removal of part of the stomach (a previous camera examination of the stomach does not disqualify you)
- You have previously taken part in any study where the drug being tested (relamorelin) was used
- You are allergic to or cannot tolerate eggs, wheat, milk, or algae, as these are part of a required stomach-emptying test during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Harvy Schneier, Allergan
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS); Change From Baseline to Week 52 in the Weekly Average DGSSS; Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE); Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results; Number of Participants With Clinically Meaningful Trends for Vital Signs; Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results; Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c);...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.