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NNC0165-1562

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 2, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

NNC0165-1562 · 2 trials · 4 indications

Phase 1 2
NCT03574584A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or ObeseMetabolism and Nutrition Disorders
COMPLETED37 Analytics
NCT02568306A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy SubjectsMetabolism and Nutrition Disorder
COMPLETED93 Analytics
PHASE1COMPLETED
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Metabolism and Nutrition Disorders
NCT0357458437
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PHASE1COMPLETED
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects
Metabolism and Nutrition Disorder
NCT0256830693
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Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
Week 0-25

Count of adverse events.

Number of treatment emergent adverse events (TEAEs), Part I (SD)
From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Number of TEAEs, Part II (MD)
From time of dosing (Day 1) until completion of the follow-up visit (Day 85)

Secondary Endpoints

AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state
Week 19 (day 134) to week 20 (day 141)
AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state
Week 19 (day 134) to week 20 (day 141)
The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)
From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0165-1562 + SemaglutideEXPERIMENTALParticipants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
Placebo (NNC0165-1562) + SemaglutideEXPERIMENTALParticipants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
NNC0165-1562EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NNC0165-1562DRUGParticipants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
SemaglutideDRUGParticipants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
Placebo (NNC0165-1562)DRUGParticipants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
placeboDRUGAdministered subcutaneously (s.c., under the skin) single dose \[SD\]) or multiple dose \[MD\] with daily dosing.
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Eligibility Criteria

Age Range19 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria: *...

Countries:United States
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Frequently asked questions about NNC0165-1562

What is NNC0165-1562 used for?

NNC0165-1562 is an investigational small molecule being developed by Novo Nordisk for metabolism and nutrition disorders, specifically overweight and obesity. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. Studies have enrolled overweight to obese but otherwise healthy subjects.

Who makes NNC0165-1562?

NNC0165-1562 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug in overweight and obese individuals.

What phase is NNC0165-1562 in?

NNC0165-1562 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 93 participants in one study and 37 in another. The drug remains investigational and has not received FDA approval.

What clinical trials is NNC0165-1562 in?

NNC0165-1562 has been studied in two completed Phase 1 trials. NCT02568306 investigated single and multiple doses in overweight to obese healthy subjects, enrolling 93 participants. NCT03574584 studied NNC0165-1562 in combination with semaglutide in overweight or obese individuals, enrolling 37 participants.

Is NNC0165-1562 the same as semaglutide?

No, NNC0165-1562 is not the same as semaglutide. It is a separate investigational small molecule developed by Novo Nordisk. One clinical trial, NCT03574584, studied NNC0165-1562 in combination with semaglutide in people who are overweight or obese, indicating they are distinct drugs being evaluated together.