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 (NCT03285308) enrolled 336 people with diabetic gastroparesis — a condition where the stomach empties more slowly than normal in people with diabetes. Participants were randomly assigned to receive either a placebo (an inactive treatment) or a drug called relamorelin (10 micrograms), with 167 people starting in the placebo group and 169 in the relamorelin group. The trial ran for 12 weeks and measured changes in four stomach-related symptoms — nausea, abdominal pain, bloating, and feeling full after eating — as well as vomiting episodes. The reported data shows that for the main (primary) symptom score — which combined all four symptoms on a scale of 0 (no symptoms) to 40 (worst possible) — both groups started at similar levels (around 25 points). By week 12, the placebo group's score had dropped by an average of 10.0 points, while the relamorelin group's score had dropped by an average of 9.3 points. For the other primary measure — the proportion of participants who had no vomiting episodes across the final six weeks of the trial — 19.5% of the placebo group and 21.8% of the relamorelin group met this criterion. The reported data for the secondary outcomes shows broadly similar results between the two groups. For nausea improvement, 34.1% in the placebo group and 29.7% in the relamorelin group met the response threshold. For abdominal pain, the figures were 28.0% and 27.9% respectively. For bloating, 26.2% (placebo) and 27.9% (relamorelin) responded, and for feeling full after eating, 22.6% (placebo) and 25.5% (relamorelin) met the response criterion. 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 ↗ · Read the linked publication on PubMed (PMID 40148033) ↗
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:
- You have been diagnosed with either Type 1 or Type 2 diabetes.
- You have been diagnosed with diabetic gastroparesis (a condition where diabetes has slowed or damaged the stomach's ability to empty food properly) and meet specific criteria set by the trial (confirm with trial site).
- You are willing and able to keep a daily diary as required by the study.
- You are willing and able to follow the study's instructions for taking the treatment correctly.
Who may not be able to join:
- You are currently receiving nutrition through a drip (IV), a tube through your nose into your stomach (nasogastric tube), or any other type of feeding tube.
- You are currently being treated for or experiencing an eating disorder such as anorexia nervosa, binge-eating disorder, or bulimia.
- You have been diagnosed with Celiac Disease, or have a history of being sensitive to gluten without having Celiac Disease.
- You have a history of other stomach or digestive conditions that could look similar to gastroparesis (confirm with trial site).
- You were diagnosed with a condition called functional dyspepsia (persistent indigestion not caused by another clear condition) before you were diagnosed with diabetes.
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: Wieslaw (Wes) Bochenek, MD, PhD, 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
4 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); Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
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.