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CompletedNCT03617081Updated Jan 10, 2020

First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.

A Phase 1 interventional study of NNC0113-2023 and Placebo (NNC0113-2023) in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2018, 7 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive).
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

Exclusion Criteria:

  • HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.
  • Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
  • Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Presence or history of pancreatitis (acute or chronic).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    NNC0113-2023

    Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.

    Drug: NNC0113-2023

  • Placebo comparator
    Placebo

    Participants will receive placebo (NNC0113-2023)

    Drug: Placebo (NNC0113-2023)

Interventions

  • DrugNNC0113-2023

    Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.

  • DrugPlacebo (NNC0113-2023)

    Participants will receive NNC0174-0833 matched placebo orally.

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Count of events

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)

Secondary outcomes

  1. AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023

    Measured in nmol/L\*h

    Time frame: From baseline (day 1) to post treatment follow-up (day 43)

  2. Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023

    Measured in nmol/L

    Time frame: From baseline (day 1) to post treatment follow-up (day 43)

  3. AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023

    Measured in ng/mL\*h

    Time frame: From baseline (day 1) to 24 hours after dosing

  4. Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023

    Measured in ng/mL

    Time frame: From baseline (day 1) to 24 hours after dosing

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78209, United States
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03617081
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Aug 9, 2018
Primary completion
Dec 13, 2018
Completion
Dec 13, 2018
Last update
Jan 10, 2020

Study contacts

Clinical Reporting Anchor and Disclosure (1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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