Back to results

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

Primary Purpose

Healthy Volunteers (Diabetes Mellitus, Type 2)

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

NNC0519-0130

Placebo (NNC0519-0130)

About this trial

This is an interventional treatment trial for Healthy Volunteers (Diabetes Mellitus, Type 2)

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Single ascending dose (SAD) part:
Male aged 18-55 years (both inclusive) at screening
Body mass index between 18.5 kilogram per meter square (kg/m^2) and 27.0 kg/m^2 (both inclusive) at screening
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
Multiple ascending dose (MAD) part:
Male aged 18-55 years (both inclusive) at screening
Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Considered eligible 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
Type 2 diabetes (T2D) part:
Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening
Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening
Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening
Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (>=) 60 days before screening
Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes
HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive)

Exclusion Criteria:

Single ascending dose (SAD) part:
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening
Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
Multiple ascending dose (MAD) part:
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening
Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening
Type 2 diabetes (T2D) part:
Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products
Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants

Sites / Locations

Novo Nordisk Investigational SiteRecruiting
Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Single ascending dose (SAD) part

Multiple ascending dose (MAD) QD part

Type 2 diabetes (T2D) part

MAD QW part

Arm Description

Participants will receive up to six dose levels of subcutaneous NNC0519-0130 or matching placebo in a sequential manner with the dose increasing between cohorts.

MAD QD part comprises two cohorts in participants with overweight or obesity and a cohort in participants with type 2 diabetes (T2D). The participants in first cohort will receive NNC0519-0130 or matching placebo subcutaneously up to 5 dose levels, and the participants in the second MAD QD cohort will receive NNC0519-0130 or matching placebo orally up to 5 dose levels.

Participants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort.

MAD QW part comprises two cohorts in participants with overweight or obesity and who are otherwise generally healthy. The participants in first cohort will receive NNC0519-0130 and 2nd cohort will receive matching placebo subcutaneously up to 6 dose levels.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort

Measured as Number of events

Number of treatment emergent adverse events (TEAE) in T2D QW cohort

Measured as number of events

Secondary Outcome Measures

AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose

Measured in h*nmol/L

Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose

Measure in nmol/L

Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort

Measured as Number of events

AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part

Measured in h*nmol/L

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part

Measured in nmol/L

AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort

Measured in h*nmol/L

Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort

Measured in nmol/L

AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort

measured in h*nmol/L

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort

Measured in nmol/L

Full Information

NCT ID

NCT05363774

First Posted

April 18, 2022

Last Updated

July 16, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05363774

Brief Title

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

Official Title

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of NNC0519-0130 in Healthy Participants and Multiple Subcutaneous and Oral Doses of NNC0519-0130 in Participants With Overweight or Obesity and Participants With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

September 18, 2023 (Anticipated)

Study Completion Date

January 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reducing overweight which is often present in participants with type 2 diabetes. In this study NNC0519-0130 is given to humans for the first time. This study will be looking into how safe the new medicine NNC0519-0130 is and will measure its concentrations in the blood. Moreover, effects on blood sugar, blood fat and body weight will be tested. There are different study parts with different participants. Healthy participants (men), healthy participants (men) with high body weight and people with diabetes (men and women) take part. Single doses and multiple doses are tested and the medicine is studied as an injection or when given orally (as a tablet). The participants are invited to take part in a part of the study which will look at the effects of weekly injected doses of NNC0519-0130 taken over the course of several weeks. It is planned that participants will be given the study medicine once weekly. The dose will be increased every three weeks, if safety and tolerability allow. Participants will take up to six different dose levels. This means that the period with weekly injections of study medicine will in total last up to 18 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Which medicine participant gets is decided by chance. The injection of study medicine will be done by trained staff into the tissue underneath the skin of belly using a syringe and needle. The total duration of the study could last up to 25 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers (Diabetes Mellitus, Type 2)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single ascending dose (SAD) part

Arm Type

Experimental

Arm Description

Participants will receive up to six dose levels of subcutaneous NNC0519-0130 or matching placebo in a sequential manner with the dose increasing between cohorts.

Arm Title

Multiple ascending dose (MAD) QD part

Arm Type

Experimental

Arm Description

Arm Title

Type 2 diabetes (T2D) part

Arm Type

Experimental

Arm Description

Participants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort.

Arm Title

MAD QW part

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

NNC0519-0130

Intervention Description

SAD part: Participants will receive up to six dose levels of subcutaneous NNC0519-0130 in a sequential manner with the dose increasing between cohorts. MAD part: The participants in first cohort will receive NNC0519-0130 subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive NNC0519-0130 up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive NNC0519-0130 up to 6 dose levels.

Intervention Type

Drug

Intervention Name(s)

Placebo (NNC0519-0130)

Intervention Description

SAD part: Participants will receive up to six dose levels of subcutaneous placebo (NNC0519-0130) in a sequential manner with the dose increasing between cohorts. MAD part: Participants in first cohort will receive placebo (NNC0519-0130) subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive placebo (NNC0519-0130) up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive Placebo up to 6 dose levels.

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part

Description

Measured as Number of events

Time Frame

From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)

Title

Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort

Description

Measured as Number of events

Time Frame

From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Title

Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort

Description

Measured as Number of events

Time Frame

From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Title

Number of treatment emergent adverse events (TEAE) in T2D QW cohort

Description

Measured as number of events

Time Frame

From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Secondary Outcome Measure Information:

Title

AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose

Description

Measured in h*nmol/L

Time Frame

From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

Title

Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose

Description

Measure in nmol/L

Time Frame

From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

Title

Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort

Description

Measured as Number of events

Time Frame

From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days)

Title

AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part

Description

Measured in h*nmol/L

Time Frame

From pre-dose (last dose in each treatment period) until 24 hours post-dose

Title

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part

Description

Measured in nmol/L

Time Frame

From pre-dose (last dose in each treatment period) until 24 hours postdose

Title

AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort

Description

Measured in h*nmol/L

Time Frame

From pre-dose (last dose) until 168 hours post-dose

Title

Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort

Description

Measured in nmol/L

Time Frame

From pre-dose (last dose) until 168 hours post-dose

Title

AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort

Description

measured in h*nmol/L

Time Frame

From pre-dose (last dose in each treatment period) until 168 hours post-dose

Title

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort

Description

Measured in nmol/L

Time Frame

From pre-dose (last dose in each treatment period) until 168 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Single ascending dose (SAD) part: Male aged 18-55 years (both inclusive) at screening Body mass index between 18.5 kilogram per meter square (kg/m^2) and 27.0 kg/m^2 (both inclusive) at screening 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 Multiple ascending dose (MAD) part (MAD QD and MAD QW): Male aged 18-55 years (both inclusive) at screening Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator Considered eligible 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 Type 2 diabetes (T2D) part: Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (>=) 60 days before screening Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive) Exclusion Criteria: Single ascending dose (SAD) part: Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening Multiple ascending dose (MAD) part (MAD QD and MAD QW): Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening Type 2 diabetes (T2D) part: Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus) Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novo Nordisk

Phone

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency dept. 2834

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Søborg

ZIP/Postal Code

2860

Country

Denmark

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

We'll reach out to this number within 24 hrs