Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes

NCT07535307 | Recruiting Phase 1

• 3 other identifiers: NN9490-8153U1111-1320-47802025-521595-55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC)

  Measured as milligram per minute per kilogram (mg/min/kg)

  Baseline to week 40

Secondary Outcomes (11)

• Change in M-value in HEC, normalised by lean body mass

  Baseline to week 40

• Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC)

  Baseline to week 40

• Change in second-phase ISR (ISR20-120 min) in HGC

  Baseline to week 40

• Change in total ISR (ISR0-120 min) in HGC

  Baseline to week 40

• Change in ISR at fixed glucose concentration (ISRg) in HGC

  Baseline to week 40

Study Arms (4)

NNC0487-0111 dose level 1

EXPERIMENTAL

Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly.

Drug: NNC0487-0111

NNC0487-0111 dose level 2

EXPERIMENTAL

Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly.

Drug: NNC0487-0111

NNC0487-0111 dose level 3

EXPERIMENTAL

Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly.

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.

Drug: Placebo

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.

NNC0487-0111 dose level 1; NNC0487-0111 dose level 2; NNC0487-0111 dose level 3

Placebo DRUG

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
• Only stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for at least 90 days before screening. If additional oral antidiabetic drug (OAD) is required, only stable dose(s) of sodium-glucose cotransporter-2 inhibitors (SGLT2i) is permitted, and this must also have been maintained for at least 90 days before screening.
• HbA1c at screening of 6.5-9.5% \[48-80 millimole per mole (mmol/mol)\] (both inclusive) if on metformin only, or 6.0-9.0% (42-75 mmol/mol) (both inclusive) if on metformin in combination with SGLT2i.

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
• Presence of type 1 diabetes.
• Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Treatment with a GLP-1 receptor agonist.
• Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days before screening.
• Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 60.0 milliliter per minute per meter square (ml/min/1.73 m\^2) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)