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Liraglutide

Phase 3

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: May 22, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment193
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04775082SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With ObesityPHASE3 ACTIVE NOT_RECRUITING 78Mar 4, 2021Feb 8, 2027May 22, 202632 United States, Belgium +7
NCT02647944Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in ObesityPHASE2 COMPLETED 40Dec 18, 2015Dec 30, 2016Oct 27, 20171 United States
NCT07225816Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)PHASE1 RECRUITING 75Nov 7, 2025Jul 17, 2026Jan 23, 20261 United States
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Study Endpoints
Primary Endpoints
Relative change in BMI (Body mass index)
From baseline (week 0) to week 56

Percent

Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
5 weeks

Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.

Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
16 weeks

Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of subcutaneous (s.c.) liraglutide once daily (Yes/No)
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

Measured as count of participants.

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

Measured as count of participants.

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

Measured as count of participants.

Secondary Endpoints
Relative change in body weight
From baseline (week 0) to week 56
Change in BMI standard deviation score (WHO.int)
From baseline (week 0) to week 56
Subjects achieving above or equal to 5 percent reduction of BMI
From baseline (week 0) to week 56
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Liraglutide 3.0 mgEXPERIMENTALThe treatment duration is 56 weeks and the follow-up period is 26 weeks.
PlaceboPLACEBO_COMPARATORThe treatment duration is 56 weeks and the follow-up period is 26 weeks.
LiraglutideACTIVE_COMPARATORSaxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
Oral semaglutideEXPERIMENTALParticipants will receive semaglutide orally.
SemaglutideEXPERIMENTALParticipants will receive semaglutide subcutaneously.
Interventions
NameTypeDescription
LiraglutideDRUGThe study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. The dose will increase each week over 4 or 5 weeks until the final dose is reached.
PlaceboDRUGThe study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
Oral SemaglutideDRUGParticipants will receive semaglutide orally.
SemaglutideDRUGParticipants will receive semaglutide subcutaneously.
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Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to dete...

Countries:United StatesBelgiumIndiaIsraelMalaysiaMexicoPortugalRussiaSwitzerland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07225816primaryCompletionDate: changed
LOWMay 26, 2026NCT04775082primaryCompletionDate: changed
LOWMay 24, 2026NCT07225816studyFirstPostDate: changed
LOWMay 24, 2026NCT04775082studyFirstPostDate: changed