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Completed

NCT Number: NCT04969939

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Univ of Alabama Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

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

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

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

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.

Primary outcomes

  1. Part 1: Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: Part 1: From time of dosing (day 1) to follow-up (week 24)

    A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.

  2. Part 2b: Percentage Change in Body Weight

    Time frame: Part 2: Randomisation (week 32), end of treatment (week 48)

    Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

Secondary outcomes

  1. Part 2b: Change in Body Weight (kg)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  2. Part 2b: Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.

  3. Part 2b: Change in Fasting Plasma Glucose (FPG)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Change in FPG (measured in millimoles per liter [mmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  4. Part 2b: Change in Fasting Insulin

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Change in fasting insulin (measured in picomoles per liter [pmol/l]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  5. Part 2b: Change in Waist Circumference

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Change in waist circumference (measured in centimeter [cm]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  6. Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  7. Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  8. Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  9. Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  10. Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  11. Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)

    Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)

    Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  12. Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)

    Time frame: From randomisation (week 32) to end of the trial (week 56)

    An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

  13. Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)

    Time frame: From randomisation (week 32) to end of the trial (week 56)

    A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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