How NNC0487-0111 affects appetite, food intake, and metabolism after meals in people with obesity

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

This test will try whether weekly injections of NNC0487-0111 reduce appetite, lower how much adults with obesity eat after meals, and change their metabolism compared with a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT07508020 on ClinicalTrials.gov

What this trial studies

This Phase 1, interventional trial randomizes adults with obesity to receive once-weekly subcutaneous injections of either NNC0487-0111 or a matched placebo. Treatments are assigned by chance and participants and staff are given matched injections to compare effects against placebo. Study visits include measurement of appetite, controlled meal intake, and post-meal metabolic measures to see how the investigational drug alters those responses. Enrollment is limited to adults 18–64 without diabetes and with stable weight prior to screening.

Who should consider this trial

Good fit: Adults age 18–64 with obesity primarily due to excess body fat, who are medically stable, not diabetic, not pregnant or breastfeeding, and able to attend on-site visits are the intended participants.

Not a fit: People with type 1 or type 2 diabetes, HbA1c ≥6.5%, pregnant or breastfeeding individuals, those on recent incretin or amylin therapies, or with recent clinically significant weight change are excluded and unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the drug could help reduce post-meal appetite and food intake and improve metabolic responses in people with obesity.

How similar studies have performed: Other incretin-related and metabolic drug programs have shown appetite and weight effects in prior studies, but NNC0487-0111 itself appears to be a novel compound being tested for these specific meal-related effects.

Eligibility criteria

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.

Where this trial is running

Berlin

• Parexel International GmbH — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Obesity