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Relamorelin

Phase 2

Diabetes Mellitus | Small molecule | Metabolic |AbbVie Inc.|Last Updated: Jul 24, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment393
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02357420Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic GastroparesisPHASE2 COMPLETED 393 — — Jan 29, 2015Jun 9, 2016Jul 24, 201998 United States, Belgium +5
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 12 in Weekly Vomiting Episodes
7 days prior to Day 1 for Baseline to 7 days prior to Week 12

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.

Secondary Endpoints
Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
7 days prior to Day 1 for Baseline to 7 days prior to Week 12
Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
Baseline (Day 1) to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Relamorelin 10 μgEXPERIMENTALRelamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
Relamorelin 30 μgEXPERIMENTALRelamorelin 30 μg was administered SC by injection BID for 12 weeks.
Relamorelin 100 μgEXPERIMENTALRelamorelin 100 μg was administered SC by injection BID for 12 weeks.
PlaceboPLACEBO_COMPARATORPlacebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Interventions
NameTypeDescription
RelamorelinDRUGDouble blind relamorelin was given subcutaneously BID for 12 weeks.
PlaceboDRUGPlacebo given subcutaneously for 12 weeks.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites98

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.,...

Countries:United StatesBelgiumGermanyIsraelPolandSwedenUnited Kingdom
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