Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RM-131
Relamorelin · 1 trial · 3 indications
Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Relamorelin 10 μg | EXPERIMENTAL | Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks. |
| Relamorelin 30 μg | EXPERIMENTAL | Relamorelin 30 μg was administered SC by injection BID for 12 weeks. |
| Relamorelin 100 μg | EXPERIMENTAL | Relamorelin 100 μg was administered SC by injection BID for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo-matching relamorelin was administered SC by injection BID for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Relamorelin | DRUG | Double blind relamorelin was given subcutaneously BID for 12 weeks. |
| Placebo | DRUG | Placebo given subcutaneously for 12 weeks. |
Inclusion Criteria: * Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) with stable glycemic control and Hemoglobin A1c (HbA1c) ≤11% at screening. * Diabetic gastroparesis (DG), defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g.,...
Relamorelin is an investigational small molecule being studied for diabetes mellitus and related complications, specifically moderate to severe diabetic gastroparesis with vomiting symptoms. It is not approved for any indication and remains in clinical development. The completed Phase 2 program enrolled 393 participants with diabetes mellitus and gastroparesis across the United States, Belgium, Germany, Israel, Poland, Sweden, and the United Kingdom.
Relamorelin targets GHSR, the growth hormone secretagogue receptor, and acts as an agonist at that receptor. This receptor is also known as the ghrelin receptor. Agonist activity at GHSR is the mechanism under investigation for its effects in diabetic gastroparesis, a condition involving delayed stomach emptying in people with diabetes mellitus.
Relamorelin is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug in diabetes mellitus and diabetic gastroparesis. The asset is a small molecule therapeutic in the metabolic therapeutic area.
Relamorelin is in Phase 2 development. It is an investigational drug and is not FDA approved. The Phase 2 trial in diabetic gastroparesis has been completed, and no active trials are currently listed for this asset. The program enrolled a total of 393 participants.
Relamorelin has been studied in one completed Phase 2 trial, NCT02357420, titled Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis. The trial was randomized, double blind, and placebo controlled, enrolling 393 adults aged 18 years and older, with no healthy volunteers, across seven countries.