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NCT Number: NCT07508020

A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity

The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Male or female (sex at birth).
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
  • Overweight should be due to excess adipose tissue, as judged by the investigator.

Key Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • History of type 1 or type 2 diabetes mellitus.
  • Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) at screening.
  • Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
  • Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Treatment and study plan

NNC0487-0111

Drug

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Placebo (matched to NNC0487-0111)

Drug

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Primary outcomes

  1. Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

    Time frame: From Baseline to Day 126

    Measured as percentage change of energy.

  2. Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

    Time frame: From Baseline to Day 182

    Measured as percentage change of energy.

  3. Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

    Time frame: From Baseline to Day 238

    Measured as percentage change of energy.

Secondary outcomes

  1. Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

    Time frame: From Baseline to Day 126

    Measured as kilojoules (kJ).

  2. Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

    Time frame: From Baseline to Day 182

    Measured as kJ.

  3. Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

    Time frame: From Baseline to Day 238

    Measured as kJ.

  4. Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126

    Time frame: From Baseline to Day 126

    Measured as grams.

  5. Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182

    Time frame: From Baseline to Day 182

    Measured as grams.

  6. Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238

    Time frame: From Baseline to Day 238

    Measured as grams.

  7. Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378

    Time frame: From Baseline to Day 378

    Measured as percentage change of energy.

  8. Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378

    Time frame: From Baseline to Day 378

    Measured as kJ.

  9. Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378

    Time frame: From Baseline to Day 378

    Measured as grams.

  10. Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126

    Time frame: From Baseline to Day 126

    Measured as kJ.

  11. Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182

    Time frame: From Baseline to Day 182

    Measured as kJ.

  12. Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238

    Time frame: From Baseline to Day 238

    Measured as kJ.

  13. Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378

    Time frame: From Baseline to Day 378

    Measured as kJ.

  14. Relative change from Day 19 in body weight to Day 131

    Time frame: From Day 19 to Day 131

    Measured as percentage change of body weight.

  15. Relative change from Day 19 in body weight to Day 187

    Time frame: From Day 19 to Day 187

    Measured as percentage change of body weight.

  16. Relative change from Day 19 in body weight to Day 243

    Time frame: From Day 19 to Day 243

    Measured as percentage change of body weight.

  17. Relative change from Day 19 in body weight to Day 383

    Time frame: From Day 19 to Day 383

    Measured as percentage change of body weight.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 27, 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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