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Glucose-dependent Insulinotropic Polypeptide

Phase 1

Overweight | Small molecule | Other |Novo Nordisk A/S|Last Updated: Apr 13, 2026

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07411560A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or ObesePHASE1 RECRUITING 100Feb 9, 2026Jan 26, 2027Apr 13, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea
From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)

Measured as number of events.

Secondary Endpoints
Total number of Adverse Events
First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+CagrilintideEXPERIMENTALParticipants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
Arm 2: Placebo GIP + Cagrilintide then GIP + CagrilintideEXPERIMENTALParticipants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.
Arm 3: GIP + Cagrilintide then Placebo GIP + CagrilintideEXPERIMENTALParticipants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
Arm 4: Placebo GIP + Cagrilintide then GIP + CagrilintideEXPERIMENTALParticipants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.
Interventions
NameTypeDescription
Glucose-dependent Insulinotropic Polypeptide (GIP)DRUGParticipants will receive GIP subcutaneously.
CagrilintideDRUGParticipants will receive Cagrilintide subcutaneously.
Placebo GIPDRUGParticipants will receive placebo matched to GIP subcutaneously.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female at birth. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. * Overweight should be due to excess adipose tissue, as ju...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07411560Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07411560studyFirstPostDate: changed