Clinical trial NCT04969939: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Part 1: Number of treatment-emergent adverse events (TEAEs)
timeFrame: From time of dosing (day 1) to follow-up (week 24)
measure: Part 2: Change in body weight
timeFrame: From randomisation (week 24) to end of treatment (week 40)
Secondary outcomes:
measure: Part 2: Change in body weight
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Change in HbA1c
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Change in fasting plasma glucose
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Change in fasting insulin
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Change in waist circumference
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in total cholesterol
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in HDL cholesterol
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in LDL cholesterol
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in VLDL cholesterol
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in Triglycerides
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Relative change in Free fatty acids
timeFrame: From randomisation (week 24) to end of treatment (week 40)
measure: Part 2: Number of emergent adverse events (TEAEs)
timeFrame: From baseline at (week 0) to end of trial (week 48)
measure: Part 2: Number of serious treatment emergent adverse events (SAEs)
timeFrame: From baseline at (week 0) to end of trial (week 48)
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Roswell
country: United States
facility: Endo Res Solutions Inc
state: Georgia
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc.
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Charleston
country: United States
facility: Medical Uni of SC Charleston
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Res Ctr.
state: South Carolina
city: Dallas
country: United States
facility: Soltero Cardiovascular Research Center
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: