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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969939
• Other study ID #: NN9775-4708
• Secondary ID: U1111-1254-9046
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2023
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Charleston	South Carolina
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Honolulu	Hawaii
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Newport News	Virginia
United States	Novo Nordisk Investigational Site	North Charleston	South Carolina
United States	Novo Nordisk Investigational Site	Overland Park	Kansas
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	Roswell	Georgia
United States	Novo Nordisk Investigational Site	Saint George	Utah
United States	Novo Nordisk Investigational Site	Skokie	Illinois
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of treatment-emergent adverse events (TEAEs)	Number of events	From time of dosing (day 1) to follow-up (week 24)
Primary	Part 2: Change in body weight	Percentage	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Change in body weight	kg	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Change in HbA1c	Percentage point	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Change in fasting plasma glucose	mmol/l	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Change in fasting insulin	pmol/l	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Change in waist circumference	cm	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in total cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in HDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in LDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in VLDL cholesterol	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in Triglycerides	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Relative change in Free fatty acids	ratio to baseline	From randomisation (week 24) to end of treatment (week 40)
Secondary	Part 2: Number of emergent adverse events (TEAEs)	Count of events	From baseline at (week 0) to end of trial (week 48)
Secondary	Part 2: Number of serious treatment emergent adverse events (SAEs)	Count of events	From baseline at (week 0) to end of trial (week 48)