A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: Tirzepatide; Drug: NNC0519-0130

• Study Type: Interventional
• Enrollment (Estimated): 343
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Not yet recruiting
      • Paratus Clinical
    • Brookvale, New South Wales, Australia, 2100
      • Recruiting
      • Northern Beaches Clinical Research
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • Holdsworth House Clinical Research
    • Kotara, New South Wales, Australia, 2289
      • Recruiting
      • Novatrials
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Not yet recruiting
      • Paratus Clinical
    • Sippy Downs, Queensland, Australia, 4556
      • Recruiting
      • University of Sunshine Coast
  • South Australia
    • Norwood, South Australia, Australia, 5067
      • Not yet recruiting
      • CMAX Clinical Research
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Not yet recruiting
      • Emeritus Research Melbourne
    • Heidelberg Heights, Victoria, Australia, 3081
      • Recruiting
      • Austin Health, Metabolic Disorders Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Withdrawn
      • Linear Clinical Research
• Japan
  • Tokyo, Japan, 160-0008
    • Recruiting
    • ToCROM Clinic
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • Recruiting
      • OCROM Clinic
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Withdrawn
      • Centricity Research-Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Withdrawn
      • Arkansas Clinical Research
    • Searcy, Arkansas, United States, 72143
      • Recruiting
      • Unity Health-Searcy Medical Center
  • California
    • Costa Mesa, California, United States, 92627
      • Recruiting
      • FDRC
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Clinical Research, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Withdrawn
      • Univ of Colorado at Denver
  • Florida
    • Crystal River, Florida, United States, 34429
      • Recruiting
      • Nature Coast Clinical Research
    • Fleming Island, Florida, United States, 32003
      • Recruiting
      • Northeast Research Institute
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Jacksonville Ctr for Clin Res
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Recruiting
      • Cedar-Crosse Research Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Midwest Inst For Clin Res
    • Valparaiso, Indiana, United States, 46383
      • Recruiting
      • Velocity Clin. Res Valparaiso
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Recruiting
      • L-MARC Research Center
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Recruiting
      • Centennial Medical Group
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Recruiting
      • StudyMetrix Research LLC
  • New York
    • New York, New York, United States, 10016
      • Not yet recruiting
      • NYU Bariatric Surgical Ctr
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Recruiting
      • PharmQuest Life Sciences LLC
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Medication Mgmnt, LLC_Grnsboro
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • Physicians East Endocrinology
    • Statesville, North Carolina, United States, 28625
      • Recruiting
      • Piedmont Healthcare
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Accellacare Wilmington
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Recruiting
      • Remington Davis Inc
    • Wadsworth, Ohio, United States, 44281-9236
      • Recruiting
      • Family Practice Center of Wadsworth Inc.
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Recruiting
      • Lynn Institute of Norman
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3317
      • Recruiting
      • The University of Penn Center
    • Pittsburgh, Pennsylvania, United States, 15243
      • Recruiting
      • Preferred Primary Care Physicians_Pittsburgh
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Recruiting
      • Velocity Clin Res Providence
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620-7352
      • Recruiting
      • Holston Medical Group Pc
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • North Texas Endocrine Center
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75226
      • Withdrawn
      • Baylr Sctt White Rs Inst, Endo
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center - Lingvay
    • Longview, Texas, United States, 75605
      • Recruiting
      • DCOL Ctr for Clin Res
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Recruiting
      • Washington Cntr Weight Mgmt
    • Newport News, Virginia, United States, 23606
      • Recruiting
      • Health Res of Hampton Roads
    • Newport News, Virginia, United States, 23606
      • Recruiting
      • TPMG Clinical Research
    • Richmond, Virginia, United States, 23294
      • Recruiting
      • National Clin Res Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female of non-childbearing potential, or male.

  a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.

• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
• b) BMI ≥ 30.0 kg/m2.

Exclusion Criteria:

• HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes mellitus.
• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing scheme a: NNC0519-0130; Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme a: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Dosing scheme b: NNC0519-0130; Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme b: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Dosing scheme c: NNC0519-0130; Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme c: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Dosing scheme d: NNC0519-0130; Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme d: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Dosing scheme e: NNC0519-0130; Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme e: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Experimental: Dosing scheme f: NNC0519-0130; Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme f: Placebo; Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.
Active Comparator: Dosing scheme g: Tirzepatide; Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.	Drug: Tirzepatide; Tirzepatide will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in percentage of body weight.	From baseline (week 0) to end of treatment (week 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measured in kilograms (kg)	From baseline (week 0) to end of treatment (week 36)
Achievement of greater than equal to (≥) 5% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 10% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 15% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 20% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)	Measured in Kilogram per meter square (Kg/m^2)	From baseline (week 0) to end of treatment (week 36)
Change in waist circumference	Measured in centimeter (cm)	From baseline (week 0) to end of treatment (week 36)
Change in glycated hemoglobin (HbA1c)	Measured in percentage point (%-point)	From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L)	From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)	Measured in milliters of mercury (mmHg)	From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive protein (hsCRP)	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in triglycerides	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score	IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).	From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Psychosocial composite score	IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).	From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Physical Function score	IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).	From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Total score	IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).	From baseline (week 0) to end of treatment (week 36)
Number of adverse events	Count of events	From baseline (week 0) to end of treatment (week 40)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): May 5, 2025

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: NN9541-5015; U1111-1291-9210 (Other Identifier: World Health Organization (WHO)); jRCT2051230198 (Registry Identifier: JRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No