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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Semaglutide 2.4 mg and placebo 2.0 mg
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Semaglutide 2.4 mg and placebo 1.0 mg
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)

Semaglutide 2.4 mg and NNC0165-1875 1.0 mg

Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)

Arm Description

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Outcomes

Primary Outcome Measures

Part 1: Number of treatment-emergent adverse events (TEAEs)
Number of events
Part 2: Change in body weight
Percentage

Secondary Outcome Measures

Part 2: Change in body weight
kg
Part 2: Change in HbA1c
Percentage point
Part 2: Change in fasting plasma glucose
mmol/l
Part 2: Change in fasting insulin
pmol/l
Part 2: Change in waist circumference
cm
Part 2: Relative change in total cholesterol
ratio to baseline
Part 2: Relative change in HDL cholesterol
ratio to baseline
Part 2: Relative change in LDL cholesterol
ratio to baseline
Part 2: Relative change in VLDL cholesterol
ratio to baseline
Part 2: Relative change in Triglycerides
ratio to baseline
Part 2: Relative change in Free fatty acids
ratio to baseline
Part 2: Number of emergent adverse events (TEAEs)
Count of events
Part 2: Number of serious treatment emergent adverse events (SAEs)
Count of events

Full Information

First Posted
July 9, 2021
Last Updated
August 10, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04969939
Brief Title
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
Official Title
Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Arm Type
Experimental
Arm Description
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Arm Title
Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Arm Title
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Arm Type
Experimental
Arm Description
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Arm Title
Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 2.4 mg and placebo 2.0 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 2.4 mg and placebo 1.0 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1: Number of treatment-emergent adverse events (TEAEs)
Description
Number of events
Time Frame
From time of dosing (day 1) to follow-up (week 24)
Title
Part 2: Change in body weight
Description
Percentage
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Secondary Outcome Measure Information:
Title
Part 2: Change in body weight
Description
kg
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Change in HbA1c
Description
Percentage point
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Change in fasting plasma glucose
Description
mmol/l
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Change in fasting insulin
Description
pmol/l
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Change in waist circumference
Description
cm
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in total cholesterol
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in HDL cholesterol
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in LDL cholesterol
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in VLDL cholesterol
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in Triglycerides
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Relative change in Free fatty acids
Description
ratio to baseline
Time Frame
From randomisation (week 24) to end of treatment (week 40)
Title
Part 2: Number of emergent adverse events (TEAEs)
Description
Count of events
Time Frame
From baseline at (week 0) to end of trial (week 48)
Title
Part 2: Number of serious treatment emergent adverse events (SAEs)
Description
Count of events
Time Frame
From baseline at (week 0) to end of trial (week 48)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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