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

Official 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

Overview

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.

Interventions

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

Primary outcome measures

• 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]
• 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]
• 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]

Secondary outcome measures (12)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Germany · 1 center

• Parexel International GmbH — Berlin

Identifiers

NCT: NCT07508020 · NN9490-8151 · U1111-1319-9246 · 2025-521393-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗