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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326060
• Other study ID #: NN9541-5015
• Secondary ID: U1111-1291-9210j
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2024
• Est. completion date: May 5, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 343
• Est. completion date: May 5, 2025
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
• Placebo
Placebo will be administered subcutaneously.
• Tirzepatide
Tirzepatide will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	Paratus Clinical	Blacktown	New South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Emeritus Research Melbourne	Camberwell	Victoria
Australia	Holdsworth House Clinical Research	Darlinghurst	New South Wales
Australia	Austin Health, Metabolic Disorders Centre	Heidelberg Heights	Victoria
Australia	Paratus Clinical	Herston	Queensland
Australia	Novatrials	Kotara	New South Wales
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	CMAX Clinical Research	Norwood	South Australia
Australia	University of Sunshine Coast	Sippy Downs	Queensland
Japan	OCROM Clinic	Suita-shi	Osaka
Japan	ToCROM Clinic	Tokyo
United States	Washington Cntr Weight Mgmt	Arlington	Virginia
United States	Univ of Colorado at Denver	Aurora	Colorado
United States	Holston Medical Group Pc	Bristol	Tennessee
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Centennial Medical Group	Columbia	Maryland
United States	Remington Davis Inc	Columbus	Ohio
United States	FDRC	Costa Mesa	California
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Baylr Sctt White Rs Inst, Endo	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	UT Southwestern Medical Center - Lingvay	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Velocity Clin Res Providence	East Greenwich	Rhode Island
United States	Northeast Research Institute	Fleming Island	Florida
United States	Medication Mgmnt, LLC_Grnsboro	Greensboro	North Carolina
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Physicians East Endocrinology	Greenville	North Carolina
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Jacksonville Ctr For Clin Res	Jacksonville	Florida
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	L-MARC Research Center	Louisville	Kentucky
United States	Centricity Research-Arizona	Mesa	Arizona
United States	NYU Bariatric Surgical Ctr	New York	New York
United States	Health Res of Hampton Roads	Newport News	Virginia
United States	TPMG Clinical Research	Newport News	Virginia
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	The University of Penn Center	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians_Pittsburgh	Pittsburgh	Pennsylvania
United States	National Clin Res Inc.	Richmond	Virginia
United States	StudyMetrix Research LLC	Saint Peters	Missouri
United States	Unity Health-Searcy Medical Center	Searcy	Arkansas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Piedmont Healthcare	Statesville	North Carolina
United States	Velocity Clin. Res Valparaiso	Valparaiso	Indiana
United States	Family Practice Center of Wadsworth Inc.	Wadsworth	Ohio
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Accellacare Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage of body weight.	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in body weight	Measured in kilograms (kg)	From baseline (week 0) to end of treatment (week 36)
Secondary	Achievement of greater than equal to (=) 5% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Secondary	Achievement of = 10% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Secondary	Achievement of = 15% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Secondary	Achievement of = 20% weight reduction	Count of participants	From baseline (week 0) to end of treatment (week 36)
Secondary	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)
Secondary	Change in waist circumference	Measured in centimeter (cm)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in glycated hemoglobin (HbA1c)	Measured in percentage point (%-point)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in systolic blood pressure (SBP)	Measured in milliters of mercury (mmHg)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in high sensitivity C-Reactive protein (hsCRP)	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in total cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in high-density lipoprotein (HDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in low-density lipoprotein (LDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in triglycerides	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of adverse events	Count of events	From baseline (week 0) to end of treatment (week 40)