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NNC0662-0419

Phase 2

Overweight | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: May 7, 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_CONTROLLEDBiomarker
Total Trials4
Total Enrollment469
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07184632A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or ObesityPHASE2 ACTIVE NOT_RECRUITING 224Oct 1, 2025Dec 14, 2026May 7, 20262 United States
NCT07525791A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body WeightPHASE1 RECRUITING 45Apr 7, 2026May 4, 2027Apr 24, 20261 United States
NCT07101783A Research Study on How a Dose of NNC0662-0419 Works in Japanese, Chinese and Non-Asian Participants Living With Overweight or ObesityPHASE1 COMPLETED 100Aug 1, 2025Oct 31, 2025Dec 23, 20251 United States
NCT06737536A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or ObesityPHASE1 COMPLETED 100Dec 18, 2024Jul 26, 2025Sep 19, 20251 United States
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Study Endpoints
Primary Endpoints
Part A: Number of treatment-emergent adverse events (TEAE)
From baseline (week 0) to end of study (up to week 44)

Measured as number of events.

Part B: Relative change in body weight
From baseline (week 0) to end of treatment (week 36)

Measured as percentage (%).

Part C: Occurrence of premature treatment discontinuation (Yes/No)
At end of treatment (week 24)

Measured as count of participants.

Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose)
Day 8 and 1 day after last NNC0662-0419 dose

Measured as picograms per milliliter (h\*pg/mL)

AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose)
Day 8 and 1 day after last NNC0662-0419 dose

Measured as h\*pg/mL

AUC; The area under the NNC0662-0419 plasma concentration-time curve
From pre-dose on Day 1 until completion of the end of study visit (Day 29)

Measured in hours\*nanomoles per liter (h\*nmol/L).

Part A: Number of treatment emergent adverse events (TEAE)
From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)

Number of events

Part B: Number of treatment-emergent adverse events (TEAE)
From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)

Number of events

Secondary Endpoints
Part A: Relative change in body weight
From baseline (week 0) to end of treatment (up to week 40)
Part A: Change in body weight
From baseline (week 0) to end of treatment (up to week 40)
Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve
From pre-dose on day 1 to completion of the end of study visit (up to week 44)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0662-0419EXPERIMENTALParticipants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
PlaceboPLACEBO_COMPARATORParticipant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
NNC0662-0419 with oral contraceptive (Altavera) and acetaminophenEXPERIMENTALParticipants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period.
NNC0662-0419 (Dose 1)EXPERIMENTALParticipants will receive a single dose (SD) of NNC0662-0419 subcutaneously.
NNC0662-0419 (Dose 2)EXPERIMENTALParticipants will receive a SD of NNC0662-0419 subcutaneously.
NNC0662-0419 (Dose 3)EXPERIMENTALParticipants will receive a SD of NNC0662-0419 subcutaneously.
Part A: Single ascending dose (SAD)EXPERIMENTALParticipants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.
Part B: Multiple ascending dose (MAD)EXPERIMENTALParticipants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.
Interventions
NameTypeDescription
NNC0662-0419DRUGNNC0662-0419 will be administered subcutaneously.
PlaceboDRUGPlacebo matched to NNC0662-0419 will be administered subcutaneously.
Oral contraceptiveDRUGAn oral contraceptive Altavera \[levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg\] will be administered orally.
AcetaminophenDRUGA single dose of acetaminophen will be administered orally.
Placebo (NNC0662-0419)OTHERParticipants will receive placebo matched to NNC0662-0419 s.c. once weekly.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria * Male or female (sex at birth). * Age at the time of signing the informed consent: * For Part A:18-55 years (both inclusive) * For Part B and Part C: 18-65 years (both inclusive) * Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as jud...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07525791primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT07184632Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07525791studyFirstPostDate: changed
LOWMay 24, 2026NCT07184632studyFirstPostDate: changed
LOWMay 21, 2026NCT07525791NEW_TRIAL: changed
LOWMay 21, 2026NCT07525791NEW_TRIAL: changed