AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
NCT07533175 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630
Last updated 2026-05-19
Summary
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Conditions
Interventions
- DRUG
-
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
- DRUG
-
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-13
- Primary Completion
- 2028-08-07
- Completion
- 2028-08-07
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Croatia
- Hungary
- Italy
- Mexico
- Romania
- Slovakia
- South Korea
Study Locations
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