Current partner codePEPTIDESDE
NCT07400107·Phase 3·INTERVENTIONAL

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Status

Not yet recruiting

Phase

Phase 3

Enrollment

1,000

Locations

120

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Interventions

Treatment arms and agents.

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

Semaglutide

Semaglutide 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 pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

DRUG

Placebo (matched to semaglutide)

Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Timeline

From registration to results.

  1. First posted

    Feb 10, 2026

  2. Study start

    May 20, 2026

  3. Primary completion

    Dec 12, 2028

  4. Study completion

    Jan 26, 2029

  5. Results posted

    Not reported

  6. Registry updated

    Mar 12, 2026

Outcomes

What the study measures.

Primary outcomes

Relative change in body weight

Time frame · From baseline (week 0) to week 84

Measured as percentage of body weight.

Secondary outcomes

Change in waist circumference

Time frame · From baseline (week 0) to week 84

Measured as centimeter (cm).

Change in systolic blood pressure (SBP)

Time frame · From baseline (week 0) to week 84

Measured as millimeter of mercury (mmHg).

Change in body weight

Time frame · From baseline (week 0) to week 84 and week 104

Measured as kilograms (kg).

Change in body mass index (BMI)

Time frame · From baseline (week 0) to week 84 and week 104

Measured as kilograms per meter squared (kg/m\^2).

Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

Time frame · From baseline (week 0) to week 84

Measured as count of participants.

Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)

Time frame · From baseline (week 0) to week 84

Measured as count of participants.

Number of participants with achievement of HbA1c < 5.7% (yes/no)

Time frame · From baseline (week 0) to week 84

Measured as count of participants.

Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)

Time frame · From baseline (week 0) to week 84

Measured as mmol/L.

Change in FPG measured as milligrams per deciliter (mg/dL)

Time frame · From baseline (week 0) to week 84

Measured as mg/dL.

Ratio to baseline: change in fasting insulin

Time frame · From baseline (week 0) to week 84

Measured as ratio.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening. * Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening. Key Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula), at screening. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Study locations

120 registered sites.

Argentina · Brazil · Bulgaria · Croatia · Germany · Hungary · India · Mexico · Poland · Portugal · Romania · Thailand · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.

Encore Medical Research LLC

Hollywood, Florida, United States

Optimal Research Sites

Orange City, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Endocrine Research Solutions, Inc

Roswell, Georgia, United States

Elite Clinical Trials

Blackfoot, Idaho, United States

Endo And Metab Cons

Rockville, Maryland, United States

Arcturus Healthcare, PLC.

Troy, Michigan, United States

Velocity Clin Res, Dallas

Dallas, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Selma Medical Associates

Winchester, Virginia, United States

Centro de Investigaciones Metabólicas

Capital Federal, Buenos Aires, Argentina

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina

Centro Médico Privado San Vicente Diabetes

Córdoba, Argentina

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, Brazil

i9 Pesquisas Clínicas

Campinas, São Paulo, Brazil

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

BR Trials - Ensaios Clínicos e Consultoria Ltda.

São Paulo, São Paulo, Brazil

Dr. Tatyana Metalova - AIPSMCE EOOD

Gotse Delchev, Bulgaria

Medical centre Zdrave 1 OOD

Kozloduy, Bulgaria

UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases

Pazardzhik, Bulgaria

MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases

Pleven, Bulgaria

DCC I- Pleven EOOD Endocrinology

Pleven, Bulgaria

MHAT Knyaginya Klementina - Sofia EAD

Sofia, Bulgaria

MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases

Sofia, Bulgaria

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Amycretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.