Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 its complications, specifically for vomiting symptoms and moderate to severe diabetic gastroparesis. It is being developed by AbbVie Inc. and is currently in Phase 2 clinical development.
Relamorelin is a small molecule that targets the ghrelin receptor. It is being studied for its potential to treat symptoms associated with diabetic gastroparesis, a complication of diabetes mellitus.
Relamorelin is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV.
Relamorelin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Relamorelin has one completed Phase 2 clinical trial, identified as NCT02357420. This trial evaluated the safety and efficacy of Relamorelin in participants with vomiting symptoms and moderate to severe diabetic gastroparesis, enrolling 393 participants across multiple countries.
Relamorelin is not known to have alternative names. It is a distinct investigational small molecule being developed by AbbVie Inc. for diabetic gastroparesis.