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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.
Must not have
Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
History of pancreatitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 64
Awards & highlights

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 below
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I am 18 years old or older.
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My BMI is over 30, or it's over 27 and I have a condition like high blood pressure or heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of medullary thyroid cancer or MEN-2 in my family or myself.
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I have had pancreatitis before.
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My obesity is caused by a hormone-related condition.
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I have been diagnosed with major depression in the past 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 64 for reporting.

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 more

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Incretin-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, enhance insulin secretion and inhibit glucagon release in response to meals, improving glycemic control and promoting weight loss. SGLT2 inhibitors reduce blood glucose by increasing urinary glucose excretion, which also aids in weight loss and lowers blood pressure. These mechanisms are crucial for Type 2 Diabetes patients as they address both hyperglycemia and obesity, common comorbidities that exacerbate the disease. Effective weight management and glycemic control can significantly reduce the risk of diabetes-related complications and improve overall health outcomes.
Effect of electroacupuncture on glucose and lipid metabolism in type 2 diabetes: A protocol for systematic review and meta-analysis.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Potential for combination of dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2 inhibitors for the treatment of type 2 diabetes.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,528 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
926,675 Total Patients Enrolled

Media Library

AMG 133 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05669599 — Phase 2
Type 2 Diabetes Research Study Groups: Cohort B: AMG 133, Cohort A: Placebo, Cohort A: AMG 133, Cohort B: Placebo
Type 2 Diabetes Clinical Trial 2023: AMG 133 Highlights & Side Effects. Trial Name: NCT05669599 — Phase 2
AMG 133 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669599 — Phase 2
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05669599 — Phase 2
~59 spots leftby Oct 2024