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
  • California
    • Walnut Creek, California, United States, 94598
      • Novo Nordisk Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Novo Nordisk Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Novo Nordisk Investigational Site
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Novo Nordisk Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Novo Nordisk Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Novo Nordisk Investigational Site
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novo Nordisk Investigational Site
    • North Charleston, South Carolina, United States, 29405
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75226
      • Novo Nordisk Investigational Site
  • Utah
    • Saint George, Utah, United States, 84790
      • Novo Nordisk Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Novo Nordisk Investigational Site
    • Richmond, Virginia, United States, 23294
      • Novo Nordisk Investigational Site

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)	Number of events	From time of dosing (day 1) to follow-up (week 24)
Part 2: Change in body weight	Percentage	From randomisation (week 24) to end of treatment (week 40)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2: Change in body weight	kg	From randomisation (week 24) to end of treatment (week 40)
Part 2: Change in HbA1c	Percentage point	From randomisation (week 24) to end of treatment (week 40)
Part 2: Change in fasting plasma glucose	mmol/l	From randomisation (week 24) to end of treatment (week 40)
Part 2: Change in fasting insulin	pmol/l	From randomisation (week 24) to end of treatment (week 40)
Part 2: Change in waist circumference	cm	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in total cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in HDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in LDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in VLDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in Triglycerides	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Relative change in Free fatty acids	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Part 2: Number of emergent adverse events (TEAEs)	Count of events	From baseline at (week 0) to end of trial (week 48)
Part 2: Number of serious treatment emergent adverse events (SAEs)	Count of events	From baseline at (week 0) to end of trial (week 48)

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): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• 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