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

NCT ID: NCT04969939

Last Updated: 2026-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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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

Group Type EXPERIMENTAL

Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

Intervention Type DRUG

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 2.0 mg)

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

Group Type PLACEBO_COMPARATOR

Semaglutide 2.4 mg and placebo 2.0 mg

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Semaglutide 2.4 mg and NNC0165-1875 1.0 mg

Intervention Type DRUG

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 1.0 mg)

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

Group Type PLACEBO_COMPARATOR

Semaglutide 2.4 mg and placebo 1.0 mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Univ of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Profil Institute For Clinical Research Inc

Chula Vista, California, United States

Site Status

Velocity Clin Res Los Angeles

Los Angeles, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Jacksonville Ctr For Clin Res

Jacksonville, Florida, United States

Site Status

Endo Res Solutions Inc

Roswell, Georgia, United States

Site Status

East West Med Res Inst

Honolulu, Hawaii, United States

Site Status

Evanston Premier Hlthcr Res

Skokie, Illinois, United States

Site Status

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

AMC Community Endocrinology

Albany, New York, United States

Site Status

NYC Research, Inc.

New York, New York, United States

Site Status

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Site Status

Accellacare

Wilmington, North Carolina, United States

Site Status

Medical Uni of SC Charleston

Charleston, South Carolina, United States

Site Status

Coastal Carolina Res Ctr.

North Charleston, South Carolina, United States

Site Status

Texas Diabetes & Endocrinology, P.A._Austin

Austin, Texas, United States

Site Status

Soltero Cardiovascular Research Center

Dallas, Texas, United States

Site Status

Texas Diabetes & Endocrinology, P.A._Austin

Round Rock, Texas, United States

Site Status

Chrysalis Clinical Research

St. George, Utah, United States

Site Status

Washington Cntr Weight Mgmt

Arlington, Virginia, United States

Site Status

Health Res of Hampton Roads

Newport News, Virginia, United States

Site Status

National Clin Res Inc.

Richmond, Virginia, United States

Site Status

Selma Medical Associates

Winchester, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1254-9046

Identifier Type: OTHER

Identifier Source: secondary_id

NN9775-4708

Identifier Type: -

Identifier Source: org_study_id

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