A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.
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ClinicalTrials.gov Identifier: NCT05363774 |
Recruitment Status :
Recruiting
First Posted : May 6, 2022
Last Update Posted : November 2, 2023
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers (Diabetes Mellitus, Type 2) | Drug: NNC0519-0130 Drug: Placebo (NNC0519-0130) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 20, 2022 |
Estimated Primary Completion Date : | March 19, 2024 |
Estimated Study Completion Date : | March 19, 2024 |
Arm | Intervention/treatment |
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Experimental: Single ascending dose (SAD) part
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.
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Drug: NNC0519-0130
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. Drug: Placebo (NNC0519-0130) 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. |
Experimental: Multiple ascending dose (MAD) QD part
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.
|
Drug: NNC0519-0130
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. Drug: Placebo (NNC0519-0130) 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. |
Experimental: Type 2 diabetes (T2D) part
Participants will receive NNC0519-0130 or matching placebo up to 2 dose levels with dose escalation within the cohort.
|
Drug: NNC0519-0130
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. Drug: Placebo (NNC0519-0130) 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. |
Experimental: MAD QW part
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.
|
Drug: NNC0519-0130
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. Drug: Placebo (NNC0519-0130) 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. |
- Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days) ]Measured as Number of events
- Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) ]Measured as Number of events
- Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort [ Time Frame: From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) ]Measured as Number of events
- Number of treatment emergent adverse events (TEAE) in T2D QW cohort [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) ]Measured as number of events
- 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 [ Time Frame: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days) ]Measured in h*nmol/L
- Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose [ Time Frame: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days) ]Measure in nmol/L
- Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days) ]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 [ Time Frame: From pre-dose (last dose in each treatment period) until 24 hours post-dose ]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 [ Time Frame: From pre-dose (last dose in each treatment period) until 24 hours postdose ]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 [ Time Frame: From pre-dose (last dose) until 168 hours post-dose ]Measured in h*nmol/L
- Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort [ Time Frame: From pre-dose (last dose) until 168 hours post-dose ]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 [ Time Frame: From pre-dose (last dose in each treatment period) until 168 hours post-dose ]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 [ Time Frame: From pre-dose (last dose in each treatment period) until 168 hours post-dose ]Measured in nmol/L
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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363774
Contact: Novo Nordisk | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
Denmark | |
Novo Nordisk Investigational Site | Recruiting |
Søborg, Denmark, 2860 | |
Germany | |
Novo Nordisk Investigational Site | Recruiting |
Neuss, Germany, 41460 |
Study Director: | Clinical Transparency dept. 2834 | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT05363774 |
Other Study ID Numbers: |
NN9541-4842 2021-004856-41 ( EudraCT Number ) U1111-1267-4254 ( Other Identifier: World Health Organization (WHO) ) |
First Posted: | May 6, 2022 Key Record Dates |
Last Update Posted: | November 2, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
URL: | http://novonordisk-trials.com |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |