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Monoclonal Antibodies
AMG 133 for Obesity With or Without Type 2 Diabetes
Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 64
Awards & highlights
Study Summary
This trial compares 3 doses of a potential weight loss drug to placebo in people with and without diabetes to see which dose works best.
Who is the study for?
Adults over 18 with obesity or overweight, who've tried and failed to lose weight through diet. Cohort A includes those without diabetes; Cohort B includes those with Type 2 diabetes, managed by diet/exercise or certain medications. Excluded are individuals with weight changes >5kg in the last 3 months, specific psychiatric disorders, history of pancreatitis, or genetic conditions like MEN-2.Check my eligibility
What is being tested?
The trial is testing three doses of AMG 133 against a placebo to see which dose is best at helping adults lose weight and maintain that loss over a year. It's divided into two groups: one for people just overweight/obese (Cohort A) and another for those also dealing with Type 2 diabetes (Cohort B).See study design
What are the potential side effects?
While not specified here, similar drugs often cause digestive issues like nausea or diarrhea, potential low blood sugar in diabetics, injection site reactions if it's an injectable drug, and sometimes headaches or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My BMI is over 30, or it's over 27 and I have a condition like high blood pressure or heart disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 64
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change From Baseline to Week 52 in Body Weight
Secondary outcome measures
Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52
Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52
Area Under the Concentration-time Curve (AUC) of AMG 133
+23 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B: AMG 133Experimental Treatment2 Interventions
Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Group II: Cohort A: AMG 133Experimental Treatment2 Interventions
Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Group III: Cohort A: PlaceboPlacebo Group2 Interventions
Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Group IV: Cohort B: PlaceboPlacebo Group2 Interventions
Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive AMG 133 or Placebo in 1 of 4 dose cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 133
2020
Completed Phase 1
~150
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,096 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,539 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a history of medullary thyroid cancer or MEN-2 in my family or myself.My BMI is over 30, or it's over 27 and I have a condition like high blood pressure or heart disease.You have gained or lost more than 5 kilograms (about 11 pounds) in the past 3 months.You have tried and failed to lose weight through dieting at least once.I have type 2 diabetes with an HbA1c between 7% and 10%, and have been managing it for over 6 months.I have had pancreatitis before.You have had a serious mental health condition or have attempted suicide in the past.You have tried and failed to lose weight through dieting at least once.My obesity is caused by a hormone-related condition.I have been diagnosed with major depression in the past 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B: AMG 133
- Group 2: Cohort A: Placebo
- Group 3: Cohort A: AMG 133
- Group 4: Cohort B: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05669599 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study include applicants who are octogenarians?
"According to this trial's eligibility standards, participants must be at least 18 years of age and no older than 99."
Answered by AI
Am I eligible to participate in this research endeavor?
"Patients with a diagnosis of obesity within the age range 18 - 99 years old may be considered for enrolment in this clinical trial. It is expected that around 570 candidates will partake in total."
Answered by AI
Has Cohort B: AMG 133 obtained authorization from the FDA?
"Cohort B: AMG 133 received a safety score of 2 based on the data provided by Power, since this is still an early stage Phase 2 trial with limited evidence for efficacy and some existing proof of safety."
Answered by AI
Are there any open spots in this trial that participants can join?
"Clinicaltrials.gov lists this trial as still open for recruitment, having been first posted on January 18th 2023 and modified most recently on February 1st 2023."
Answered by AI
How many volunteers have enrolled in this experiment?
"Affirmative. Data hosted on clinicaltrials.gov shows that this medical study, which was initially advertised on January 18th 2023, is actively recruiting. Approximately 570 volunteers must be found from 2 different sites in order to complete the trial."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Texas
Other
Ohio
What site did they apply to?
Ark Clinical Research- Long Beach
Foothills Research Center
Medical Care LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
What questions have other patients asked about this trial?
Is the location in Cincinnati Ohio? There are few details offered. How do you qualify? When is the start date, and how long does it last? Where and how often/long are the visits? What were some of the side effects in the first phase?
PatientReceived no prior treatments
Why did patients apply to this trial?
Failed in the past. Looking to loose weight. I would like to get out pills and this sickness.
PatientReceived 1 prior treatment
Trying to help other people, and maybe myself too. I have tried dieting last year with no luck, hope this helps me.
PatientReceived 2+ prior treatments
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