A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; Drug: Semaglutide 2.4 mg and placebo 2.0 mg; Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; Drug: Semaglutide 2.4 mg and placebo 1.0 mg

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Univ of Alabama Birmingham
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Chula Vista, California, United States, 91911
      • Profil Institute For Clinical Research Inc
    • Los Angeles, California, United States, 90017
      • Velocity Clin Res Los Angeles
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Ctr For Clin Res
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Endo Res Solutions Inc
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East West Med Res Inst
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Evanston Premier Hlthcr Res
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • New York
    • Albany, New York, United States, 12206
      • AMC Community Endocrinology
    • New York, New York, United States, 10016
      • NYC Research, Inc.
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical Uni of SC Charleston
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Res Ctr.
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology, P.A._Austin
    • Dallas, Texas, United States, 75226
      • Soltero Cardiovascular Research Center
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A._Austin
  • Utah
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Washington Cntr Weight Mgmt
    • Newport News, Virginia, United States, 23606
      • Health Res of Hampton Roads
    • Richmond, Virginia, United States, 23294
      • National Clin Res Inc.
    • Winchester, Virginia, United States, 22601-3834
      • Selma Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.

Exclusion Criteria:

• HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

  • History of type 1 or type 2 diabetes mellitus.
  • Treatment with glucose-lowering agent(s) 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg	Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Placebo Comparator: Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg); Participants will receive placebo as an add on to semaglutide 2.4 mg.	Drug: Semaglutide 2.4 mg and placebo 2.0 mg; NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Experimental: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg	Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Placebo Comparator: Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg); Participants will receive placebo as an add on to semaglutide 2.4 mg.	Drug: Semaglutide 2.4 mg and placebo 1.0 mg; NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)	A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.	Part 1: From time of dosing (day 1) to follow-up (week 24)
Part 2b: Percentage Change in Body Weight	Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2: Randomisation (week 32), end of treatment (week 48)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2b: Change in Body Weight (kg)	Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)	Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Plasma Glucose (FPG)	Change in FPG (measured in millimoles per liter [mmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Fasting Insulin	Change in fasting insulin (measured in picomoles per liter [pmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Change in Waist Circumference	Change in waist circumference (measured in centimeter [cm]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)	Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)	Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)	Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)	Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)	Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)	Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	Part 2b: Randomisation (week 32), end of treatment (week 48)
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	From randomisation (week 32) to end of the trial (week 56)
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)	A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.	From randomisation (week 32) to end of the trial (week 56)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; semaglutide
• Other Study ID Numbers: NN9775-4708; U1111-1254-9046 (Other Identifier: WHO)

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
• product manufactured in and exported from the U.S.: No