NCT07578584

Brief Summary

The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
May 2026Feb 2028

First Submitted

Initial submission to the registry

May 5, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2028

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 5, 2026

Last Update Submit

June 1, 2026

Conditions

Type 1 Diabetes (T1D)OverweightObesityHealthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Number of adverse events

    Measured in events

    Day 1 up to Week 6

  • Number of adverse events

    Measured in events

    MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25

  • Number of adverse events

    Measured in events

    Day 1 up to Week 25

Secondary Outcomes (7)

  • Area under the serum NNC0497-0040 concentration time curve

    Day 1

  • Cmax: Maximum observed serum NNC0497-0040 concentration

    Day 1

  • Area under the serum NNC0497-0040 concentration time curve at steady state

    MAD1-2: Week 12; MAD3: Week 20

  • Cmax: Maximum observed serum NNC0497-0040 concentration at steady state

    MAD1-2: Week 12; MAD3: Week 20

  • Number of severe hypoglycaemic episodes

    Day 1 up to Week 25

  • +2 more secondary outcomes

Study Arms (5)

SAD

EXPERIMENTAL

Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Drug: NNC0497-0040Drug: Placebo

MAD1

EXPERIMENTAL

Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Drug: NNC0497-0040Drug: Placebo

MAD2

EXPERIMENTAL

Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Drug: NNC0497-0040Drug: Placebo

MAD3

EXPERIMENTAL

Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Drug: NNC0497-0040Drug: Placebo

MAD4

EXPERIMENTAL

Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

Drug: NNC0497-0040Drug: Placebo

Interventions

NNC0497-0040DRUG

NNC0497-0040 will be administered subcutaneously.

MAD1MAD2MAD3MAD4SAD
PlaceboDRUG

Placebo will be administered subcutaneously.

MAD1MAD2MAD3MAD4SAD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
  • Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per 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.

You may not qualify if:

  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
  • Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
  • For MAD1-3 cohorts
  • Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
  • Body mass index between 27.0 kilogram per m\^2 and 39.9 kilogram per 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.
  • Any disorder, unwillingness or inability 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 above or equal to 6.5 percentage (48 millimoles per mole) at screening.
  • Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
  • For MAD4 cohorts
  • Male aged 18-55 years (both inclusive) at screening.
  • Body mass index between 27.0 kilogram per m\^2 and 34.9 kilogram per m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1OverweightObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Transparency dept. 2834

    Novo Nordisk A/S

    STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178clinicaltrials@novonordisk.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

February 18, 2028

Study Completion (Estimated)

February 18, 2028

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

More information

Locations

DE(1)