GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

—

Enrollment

592

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c 7-10%

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05669599

Org study ID20190218

Secondary ID2023-510470-13-00

Timeline

Milestones

Study first posted2023-01-03actual

Study start2023-01-18actual

Primary completion2024-10-08actual

Study completion2025-12-16actual

Last update posted2026-01-20actual

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥18 years at the time of signing informed consent.

•BMI ≥30 kg/m^2, or ≥27 kg/m^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.

•For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.

•History of at least one unsuccessful dietary effort to lose body weight.

Exclusion criteria

•Change in body weight greater than 5 kg within 3 months prior to screening.

•Obesity induced by other endocrinologic disorders.

•History of pancreatitis.

•Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).

•History of major depressive disorder within the last 2 years.

•Any lifetime history of other major psychiatric disorder or suicide attempt.

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

10 endpoints

Primary/protocol endpoint

Percent Change From Baseline to Week 52 in Body Weight

Time frame:Baseline and Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52

Time frame:Baseline and Week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52

Time frame:Baseline and Week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52

Time frame:Baseline and Week 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52

Time frame:Baseline and Week 52

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Waist Circumference

Time frame:Baseline and Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Body Weight

Time frame:Baseline and Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)

Time frame:Baseline and Week 52

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Lean Body Mass Using DEXA

Time frame:Baseline and Week 52

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Body Mass Index (BMI)

Time frame:Baseline and Week 52

BMI, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline to Week 52 in Fasting Serum Insulin

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Fasting Plasma Glucose

Time frame:Baseline and Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)

Time frame:Baseline and Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)

Time frame:Baseline and Week 52

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)

Time frame:Baseline and Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)

Time frame:Baseline and Week 52

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline and Week 52

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline in Total Cholesterol

Time frame:Baseline and Week 52

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline and Week 52

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change From Baseline in non-HDL-C

Time frame:Baseline and Week 52

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)

Time frame:Baseline and Week 52

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Triglycerides

Time frame:Baseline and Week 52

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Free Fatty Acids (FFA)

Time frame:Baseline and Week 52

Free fatty acids, change

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide

Time frame:Up to Week 64

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide

Time frame:Up to Week 64

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity - A Phase 2 Trial.
The New England journal of medicine2025 Sep 4PMID40549887doi:10.1056/NEJMoa2504214via CT.gov background + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.