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Apelin

Phase 2

Cardiovascular Diseases | Small molecule | Cardiovascular |AstraZeneca PLC|Trials Updated: Sep 30, 2026

Apelin development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Oct 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Apelin clinical trials

Apelin · 1 trial · 2 indications

Phase 2 1
NCT03449251A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxinCardiovascular Diseases
ACTIVE NOT_RECRUITING170 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin
Cardiovascular Diseases
NCT03449251170
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Study Endpoints

Primary Endpoints

Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucose)
Visit 2 to visit 4, over a period of up to 8 weeks

Glucose, in mmol/l

Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (C-Peptide)
Visit 2 to visit 4, over a period of up to 8 weeks

C-peptide, in pmol/L

Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucagon)
Visit 2 to visit 4, over a period of up to 8 weeks

Glucagon, in pg/ml

Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Insulin)
Visit 2 to visit 4, over a period of up to 8 weeks

Insulin, in pmol/L

Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (TNF-alpha)
Visit 2 to visit 4, over a period of up to 8 weeks

TNF-alpha, in pg/ml

Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Visit 2 to visit 5, over a period of up to 14 weeks

Glucose, in mmol/l

Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Absolute Flow)
Within visit 2, over a period of up to 4 weeks

Absolute flow in the infused arm, in mg/dL/min

Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Percentage Change)
Within visit 2, over a period of up to 4 weeks

Percentage change in the infused arm, in %

Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Ratio)
Within visit 2, over a period of up to 4 weeks

Ratio, expressed as a number (no units as this is a ratio)

Sub-study 2b: Change in forearm blood flow parameters in healthy participants after infusion of relaxin in the presence of L-NMMA or normal saline
Visit 2 to visit 3, over a period of up to 10 weeks

Ratio; absolute flow and percentage change in the infused arm

Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Ratio)
Visit 2 to visit 3, over a period of up to 10 weeks

Ratio; expressed as a number (no units as this is a ratio)

Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Absolute Flow)
Visit 2 to visit 3, over a period of up to 10 weeks

Absolute flow in the infused arm, in mg/dL/min

Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Percentage Change)
Visit 2 to visit 3, over a period of up to 10 weeks

Percentage change in the infused arm, In %

Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin
Visit 2 to visit 3, over a period of up to 10 weeks

Ratio; absolute flow and percentage change in the infused arm

Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Ratio)
Visit 2 to visit 3, over a period of up to 10 weeks

Ratio, expressed as a number (no units as this is a ratio)

Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Absolute Flow)
Visit 2 to visit 3, over a period of up to 10 weeks

Absolute flow in the infused arm, in mg/dL/min

Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Percentage Change)
Visit 2 to visit 3, over a period of up to 10 weeks

Percentage change in the infused arm, In %

Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Ratio)
Visit 2 to visit 3, over a period of up to 10 weeks

Ratio, expressed as a number (no units as this is a ratio)

Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Absolute Flow)
Visit 2 to visit 3, over a period of up to 10 weeks

Absolute flow in the infused arm, in mg/dL/min

Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Percentage Change)
Visit 2 to visit 3, over a period of up to 10 weeks

Percentage change in the infused arm, In %

Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucose)
Visit 2 to Visit 4, over a period of up to 8 weeks

Glucose, in each of the groups, in mmol/L

Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (C-peptide)
Visit 2 to Visit 4, over a period of up to 8 weeks

C-peptide, in each of the groups, in pmol/L

Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucagon)
Visit 2 to Visit 4, over a period of up to 8 weeks

glucagon, in each of the groups,in pg/ml

Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Insulin)
Visit 2 to Visit 4, over a period of up to 8 weeks

Insulin, in each of the groups, in pmol/L

Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (TNF-alpha)
Visit 2 to Visit 4, over a period of up to 8 weeks

TNF-alpha, in each of the groups, in pg/ml

Sub-study 5: Change in hand vein diameter after relaxin infusion in healthy participants
Visit 2

Hand vein Demeter is measured using Aellig dorsal hand vein technique

Secondary Endpoints

Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Echocardiography)
Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Innocor)
Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Bioimpedance)
Visit 2 to visit 4, over a period of up to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Substudy 1A - ApelinEXPERIMENTALIn sub-study 1A Healthy participants will receive systemic infusions of Apelin to establish a dose range
Substudy 1B - Apelin/Normal SalineEXPERIMENTALIn sub-study 1B , individuals with Type 2 Diabetes and individuals with increase weight will receive systemic infusions of Apelin or Normal Saline
Substudy 2A - Relaxin/Normal SalineEXPERIMENTALIn sub-study 2A Healthy participants will receive intra-arterial infusions of Relaxin
Substudy 2B - RelaxinEXPERIMENTALIn sub-study 2B Healthy participants will receive intra-arterial infusions of Relaxin followed by verapamil (on a background infusion of either LN Monomethyl Arginine or Normal Saline, to test effects on nitric oxide)
Substudy 3A - Relaxin with Apelin/SalineEXPERIMENTALIn sub-study 3A Healthy participants will receive intra-arterial infusions of Relaxin (background infusion apelin/Normal Saline)
Substudy 3B - Apelin with Relaxin/SalineEXPERIMENTALIn sub-study 3B Healthy participants will receive intra-arterial infusions of Apelin (background infusion Relaxin/Normal Saline)
Substudy 4 - Apelin and RelaxinEXPERIMENTALIn sub-study 4 Healthy participants, Individuals with Type 2 Diabetes and Individuals with increase weight will receive systemic infusions of Normal saline, Relaxin, Apelin and relaxin
Substudy 5 - Relaxin/SalineEXPERIMENTALIn sub-study 5 Healthy participants will be allocated to 1 of 4 Relaxin dosing groups and will receive dorsal hand vein infusion of 3 incremental doses of Normal Saline/ D5W and Relaxin

Interventions

NameTypeDescription
ApelinDRUGApelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.
RelaxinDRUGRelaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.
Normal salineDRUGVehicle
VerapamilDIAGNOSTIC_TESTNO independent challenge agent
LN Monomethyl arginineDIAGNOSTIC_TESTBasal NO synthase inhibitor
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy participants * Have given written informed consent to participate * Aged 18 to 70 years inclusive * Male or female * Current non-smoker * If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit ...

Countries:United Kingdom
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Competitive Landscape -General Cardiovascular Diseases 67 trials (matched to "Cardiovascular Diseases")

Top 4 of 19 competitors

CompanyTickerTrialsLead PhaseDrugs
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Roivant Sciences Ltd.ROIV3PHASE3Mosliciguat
Eli Lilly and CompanyLLY1PHASE3Lepodisiran
Illumina, Inc.ILMN1PHASE118F-mFBG for administration
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