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Long‑term Efficacy, Safety and Tolerability of maridebart cafraglutide in Adults with Obesity and Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have obesity or are overweight and also have Type 2 Diabetes Mellitus. Participants will receive a once‑weekly injection under the skin (subcutaneous use) of the investigational medicine maridebart cafraglutide or a matching placebo. The medication is given as a clear liquid that is injected with a small needle.

The main aim of the trial is to see how the medicine affects body weight over a long period and to evaluate its safety and how well it is tolerated. After enrollment, participants will attend regular clinic visits where the injection is given, vital signs are checked, and blood samples are taken. The study continues for several months, allowing researchers to track changes in weight and health over time.

Safety is closely monitored, and any side effects or problems are recorded. In addition to weight, the study measures a blood test called HbA1c, which reflects average blood sugar levels, to understand the impact on diabetes control. Participants also complete questionnaires about how weight changes affect daily activities and overall quality of life.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and study identification

    After you have given informed consent, you receive a unique study identification number that will be used for all trial activities.

  2. Step 2

    Baseline assessments

    During the first visit, clinical staff measure your body weight, waist circumference, and blood sugar level (hbA1c, a test that shows average blood sugar over the past few months).

    You also complete a questionnaire about how your weight affects daily activities.

  3. Step 3

    Randomization to treatment

    Based on a computer‑generated schedule, you are randomly assigned to receive either maridebart cafraglutide (the investigational drug) or a matching placebo. the assignment is double‑blind, meaning you and the study staff do not know which product you receive.

  4. Step 4

    Medication administration

    You receive a subcutaneous injection (injection under the skin) of the assigned product at each scheduled visit.

    The injection is a solution for injection; the exact dose is defined by the study protocol (listed as 0 mg in the product information, indicating the dose is determined by the trial).

    Injections are given according to the study schedule, which continues for the duration of the extension trial.

  5. Step 5

    Regular follow‑up visits

    At each follow‑up visit you undergo repeat measurements of body weight, waist circumference, and hbA1c.

    You answer questions about any side effects or health changes since the previous visit.

    The frequency of visits follows the trial schedule, typically occurring every few weeks throughout the study period.

  6. Step 6

    Safety monitoring

    Clinical staff review any adverse events (undesired health changes) you report and assess their seriousness.

    This monitoring continues at every visit to ensure your safety while you remain in the trial.

  7. Step 7

    Study duration

    The extension trial is planned to run until the overall study end date of 2028‑03‑17.

    Your participation continues for the full length of the trial unless you withdraw earlier or are discontinued for safety reasons.

  8. Step 8

    Final assessment and study completion

    At the last scheduled visit, you undergo the same set of measurements performed at baseline, including body weight, waist circumference, hbA1c, and quality‑of‑life questionnaire.

    After these final assessments, the trial is concluded for you and you are informed of the study completion.

Who can join the trial?

5 criteria

  • You must sign an informed consent form, which means you agree to join the study and understand the rules and requirements.
  • You must have finished the earlier study called the parent trial and you must not have stopped the study medication permanently.
  • You must have been placed into a treatment group, a process known as randomized, within 7 days after the week‑72 visit of the parent trial.
  • You must use the birth‑control method required by the study, called protocol‑specified contraception, while taking the study drug and for 16 weeks after your last dose.
  • You can be either male or female, must be a patient, and must be within the age range set by the study.

Who cannot join the trial?

14 criteria

  • Planned surgical, endoscopic, or device‑based treatment for obesity during the study period.
  • Any other serious health problem (such as drug or alcohol abuse, eating disorders, or other conditions) that the doctor thinks could be unsafe for you.
  • Currently pregnant, breastfeeding, or planning to become pregnant or breastfeed while in the study and for 16 weeks after the last dose.
  • Major surgical procedure planned during the study.
  • Minor surgery that does not require general anesthesia may be allowed, but only if the doctor decides it is safe.
  • People who work on the study or their immediate family members (spouse, parent, child, or sibling) cannot take part.
  • Body mass index (BMI) ≤ 18.5 kg/m² (considered underweight).
  • Known allergy or sensitivity to any of the study medication or its ingredients.
  • History of ischemic optic neuropathy (damage to the eye’s optic nerve caused by reduced blood flow).
  • Any cancer diagnosed during the earlier trial, except for certain early‑stage skin cancers and early‑stage breast, cervical, or prostate cancers that have been treated with the goal of cure.
  • Newly identified multiple endocrine neoplasia syndrome type 2 or a first‑degree relative (parent, sibling, or child) with medullary thyroid carcinoma (a specific type of thyroid cancer).
  • PHQ‑9 score ≥ 15 at the week‑72 visit (a questionnaire that measures the severity of depression).
  • Severe suicidal thoughts (category 4 or 5) or any suicidal behavior on the Columbia‑Suicide Severity Rating Scale (C‑SSRS) at the week‑72 visit.
  • If the doctor believes you are unlikely to complete all required study visits, procedures, and restrictions.
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Investigated drugs

AMG 133 is the investigational drug being studied in this trial. It contains the active ingredient maridebart cafraglutide and is given as a liquid that is injected under the skin. The purpose of using AMG 133 is to see if it can help people who are overweight or have obesity and also have type 2 diabetes lose weight over a long period, while also checking that it is safe and well‑tolerated.

What is already known about the treatment

Maridebart Cafraglutide - Maridebart Cafraglutide is given as a liquid that is injected under the skin. It is still an experimental drug and is currently being studied in phase 3 clinical trials for weight management in people with obesity or overweight and type 2 diabetes. The medicine works by activating a natural hormone that helps lower blood sugar and reduces appetite, leading to weight loss. It belongs to the class of GLP‑1 receptor agonist peptide medicines.

Investigated diseases

Obesity - Obesity is a chronic condition characterized by excess body fat, usually defined by a body‑mass index of 30 kg/m² or higher. It develops when energy intake consistently exceeds energy expenditure, leading to gradual accumulation of adipose tissue. Over time the amount of stored fat can increase, making weight loss more difficult and the condition more entrenched. The body’s metabolism and appetite signals may adapt, further promoting weight gain. Without effective changes, the excess weight tends to persist or progress.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524788-19-00Protocol code20210182Estimated enrolment950 patientsSponsorAmgen Inc.

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