Back to Search Results
Recruitment Complete
Sponsor ID
20190218

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

Sponsor ID
20190218
Clinicaltrials.gov ID
NCT05669599
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
592
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change From Baseline to Week 52 in Body Weight

Timeframe: Baseline and Week 52

Secondary Outcome Measures

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

Change from Baseline to Week 52 in Fasting Serum Insulin

Timeframe: Baseline and Week 52

Change from Baseline to Week 52 in Fasting Plasma Glucose

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide

Timeframe: Up to Week 64

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

Timeframe: Up to Week 64

Change from Baseline to Week 52 in Waist Circumference

Timeframe: Baseline and Week 52

Change from Baseline to Week 52 in Body Weight

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

Percent Change From Baseline in Total Cholesterol

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

Percent Change From Baseline in non-HDL-C

Timeframe: Baseline and Week 52

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

Timeframe: Baseline and Week 52

Percent Change From Baseline in Triglycerides

Timeframe: Baseline and Week 52

Percent Change From Baseline in Free Fatty Acids (FFA)

Timeframe: Baseline and Week 52

Locations

Location
Status
Contact Us
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Recruiting
Location
East-West Medical Research
Honolulu, HI, United States, 96814
Status
Recruiting
Location
Foothills Research Center
Phoenix, AZ, United States, 85044
Status
Recruiting
Location
St Vincents Hospital Melbourne
Fitzroy, VIC, Australia, 3065
Status
Recruiting
Location
Ark Clinical Research- Tustin
Tustin, CA, United States, 92780
Status
Recruiting
Location
Nakakinen Clinic
Naka-shi, Ibaraki, Japan, 311-0113
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 99 Years
Condition
  • Weight Loss & Obesity
    • Show more
  • Diabetes
    • Sex
    All
    Trial Dates
    Jan 2023 - Oct 2024
    Inclusion and Exclusion Criteria
    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.