A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

NCT07415954
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
270
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Lead sponsor
Novo Nordisk A/S
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Start date
2026-04-17
clinicaltrials.gov
Number of sites
63
clinicaltrials.gov

Summary
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
clinicaltrials.gov
Short title
A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes
clinicaltrials.gov
Official title
Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-10-01
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First posted
2026-02-17
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Registry last updated
2026-08-10
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Primary completion date
2027-09-03
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Start date
2026-04-17
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Participants
270
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Participant count basis
Estimated
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Planned participants
270
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Protocol amendments
1
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Number of sites
63
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07415954
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ClinicalTrials.gov ID
NCT07415954
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change in glycated haemoglobin (HbA1c) (week 16)

    Timeframe: From baseline (week 0) to week 16

    Measured as percentage-point (%-point).

  2. Change in HbA1c (week 28)

    Timeframe: From baseline (week 0) to week 28

    Measured as %-point.

  3. Change in HbA1c (week 40)

    Timeframe: From baseline (week 0) to week 40

    Measured as %-point.

  1. Relative change in body weight

    Timeframe: From baseline (week 0) to (week 40)

    Measured as percentage (%).

  2. Change in body weight

    Timeframe: From baseline (week 0) to (week 40)

    Measured as kilogram (kg).

  3. Change in HbA1c

    Timeframe: From baseline (week 0) to (week 16, 28 and 40)

    Measured as %-point.

  4. Change in Fasting Plasma Glucose (FPG)

    Timeframe: From baseline (week 0) to (week 16, 28 and 40)

    Measured as millimoles per litre (mmol/L).

  5. Change in Body Mass Index (BMI)

    Timeframe: From baseline (week 0) to (week 40)

    Measured in kilograms per square metre (kg/m\^2).

  6. Change in waist circumference

    Timeframe: From baseline (week 0) to (week 40)

    Measured in centimetre (cm).

  7. Change in high sensitivity C-Reactive Protein (hsCRP)

    Timeframe: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  8. Change in total cholesterol

    Timeframe: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  9. Change in High-Density Lipoprotein (HDL) cholesterol

    Timeframe: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  10. Change in Low-Density Lipoprotein (LDL) cholesterol

    Timeframe: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  11. Change in triglycerides

    Timeframe: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  12. Change in Urine Albumin Creatinine Ratio (UACR)

    Timeframe: From baseline (week 0) to (week 16, 28 and 40)

    Measured as ratio to baseline.

  13. Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021)

    Timeframe: From baseline (week 0) to (week 40)

    Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m\^2).

  14. Number of adverse events

    Timeframe: From baseline (week 0) to (week 48)

    Measured as number of events.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • Male or female (sex at birth).
  • Age 18-75 years (both inclusive) at the time of signing the informed consent.
  • Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening.
  • Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.
Sources for eligibility
clinicaltrials.gov

  • First Valley Medical GroupLancaster, United StatesRecruiting
  • Torrance Clinical Research Institute, Inc.Lomita, United StatesRecruiting
  • Ark Clinical ResearchLong Beach, United StatesRecruiting
  • Pacific Clinical StudiesLos Alamitos, United StatesRecruiting
  • Wetlin Research Associates, Inc.San Diego, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Encore Medical Research LLCHollywood, United StatesRecruiting
  • Bioclinical Research AllianceMiami, United StatesRecruiting
  • South Broward Research LLCMiramar, United StatesRecruiting
  • West Orange EndocrinologyOcoee, United StatesNot yet recruiting
  • Encore Medical Research of WestonWeston, United StatesRecruiting
  • Elite Clinical TrialsBlackfoot, United StatesRecruiting
  • Cedar-Crosse Research CenterChicago, United StatesRecruiting
  • Brigham & Women's HospitalBoston, United StatesNot yet recruiting
  • Headlands ResearchSpringfield, United StatesRecruiting
  • PharmQuestGreensboro, United StatesRecruiting
  • Piedmont Healthcare StatesvilleStatesville, United StatesRecruiting
  • Providence Center for Clinical ResearchDayton, United StatesRecruiting
  • CNS HealthcareMemphis, United StatesRecruiting
  • University of Texas Southwestern Medical CenterDallas, United StatesRecruiting
  • JCCT- Juno NW HoustonHouston, United StatesRecruiting
  • Consano Clinical Research, LLCShavano Park, United StatesRecruiting
  • Frontier Clinical Research - KingwoodKingwood, United StatesNot yet recruiting
  • Opca bolnica KarlovacKarlovac, CroatiaRecruiting
  • Poliklinika SLAVONIJA OSIJEKOsijek, CroatiaRecruiting

And 38 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523260-20
  • U1111-1324-0310
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)