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Retatrutide Injection

Efficacy, Study Data, Use in Clinical Trials, and Current Regulatory Status

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Dr. Nicolette Lammers.

What is Retatrutide?

Retatrutide is an injectable investigational medication containing the active ingredient retatrutide. The drug is currently being studied in clinical trials for the treatment of obesity, overweight with weight-related comorbidities, and type 2 diabetes. Unlike classic GLP-1-based medications, retatrutide does not act only through GLP-1, but also through GIP and glucagon receptors.

In clinical trials, it is administered as a once-weekly subcutaneous injection, meaning an injection under the skin. Early study results are considered promising. Still, one point is important: retatrutide is currently not approved in Germany or in the European Union. The Body Clinic does not currently prescribe retatrutide.

If you are interested in treatment options that are currently available, you can find more information about losing weight with injections as well as on our pages about Wegovy and Mounjaro.

If you would like a medical assessment of currently available treatment options, you can get advice at our locations or nationwide via online video consultation.

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    Who is Retatrutide suitable for?

    Retatrutide is currently not a regularly available medication, but an active ingredient in clinical development. In the studies conducted so far, retatrutide is being investigated, among other things, in adults with obesity, in adults with overweight and weight-related comorbidities, and in adults with type 2 diabetes.

    Whether retatrutide will eventually be approved for specific patient groups depends on further study results and decisions by regulatory authorities. For individual medical assessment, not only weight and body mass index are relevant, but also comorbidities, concurrent medication, tolerability, and the specific treatment goal.

    What is Retatrutide approved for?

    Retatrutide is currently not approved in Germany or in the European Union. At present, there is no regular prescribing option and no regulatory approval for routine clinical use. The active ingredient continues to be studied in phase 3 trials, including in obesity and type 2 diabetes.

    This classification is also important for patients in Germany: The Body Clinic does not currently prescribe retatrutide. If you are interested in treatment options that are already available, you can find more information about medical weight loss with injections, Wegovy, and Mounjaro.

    How does Retatrutide work?

    Retatrutide is a so-called triple agonist. The active ingredient activates receptors for GIP, GLP-1, and glucagon at the same time. This distinguishes retatrutide from currently available medications such as Wegovy or Mounjaro, which have different pharmacologic profiles.

    Based on current scientific understanding, retatrutide may therefore influence appetite, satiety, blood sugar regulation, and energy balance. In a phase 2 study in adults with obesity or overweight without diabetes, substantial weight reduction was observed with retatrutide. However, such study results do not constitute regulatory approval and are not a fixed expectation for an individual case.

    How is Retatrutide used?

    In clinical trials, retatrutide is administered as a subcutaneous injection, meaning an injection under the skin. It is given once weekly. Because the active ingredient is currently not approved, there is no routinely authorized recommendation for everyday clinical use in Germany.

    Use in clinical trials

    Different dose strengths have been investigated in the studies conducted so far. In these trials, the active ingredient was gradually dose-escalated to improve tolerability. However, such study regimens are not equivalent to an approved standard therapy and should not be understood as a basis for independent use.

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    Who developed Retatrutide?

    Manufacturer

    Retatrutide is being developed by Eli Lilly. The active ingredient belongs to the newer pharmacologic approaches in obesity and type 2 diabetes and differs from many other medications in that it acts simultaneously on GIP, GLP-1, and glucagon receptors.

    Availability in Germany

    Retatrutide is currently not approved in Germany and is not regularly available. The active ingredient remains in clinical development and is currently being investigated in phase 3 trials. It therefore cannot currently be prescribed in routine clinical care. If you are interested in treatment options that are already available, you can find more information on our pages about Wegovy and Mounjaro.

    Where can I buy Retatrutide?

    Retatrutide is currently not available over the counter and is not regularly available through pharmacies in Germany. At present, the active ingredient is only available within clinical trials. The Body Clinic does not currently offer retatrutide and does not prescribe it at this time.

    Which medication options are actually available at present and may be medically appropriate in an individual case should always be assessed by a physician. You can find an overview of our currently available programs on our page Prices for medical weight loss.

    What are the possible side effects?

    The study data published so far mainly show gastrointestinal symptoms as common side effects. These occurred especially during dose escalation and have also been described in similar form with other incretin-based therapies.

    • Nausea
    • Diarrhea
    • Vomiting
    • Constipation
    • Reduced appetite

    In studies, altered sensations such as dysesthesia as well as temporary increases in heart rate were also observed. Because retatrutide has not yet been approved, its safety profile continues to be evaluated in ongoing trials. For that reason, it is important not to view the active ingredient as a regularly available treatment.

    When should medical advice be sought?

    Because retatrutide is currently not an approved medication for routine clinical use, it should not be used independently outside clinical trials. Regardless of that, severe or persistent symptoms such as intense abdominal pain, repeated vomiting, significant fluid loss, or symptoms that worsen rapidly should always be medically assessed promptly.

    Safety, interactions, and contraindications

    At present, there is no approved prescribing information for the routine use of retatrutide in Germany. This also means that there is no regulator-approved standard use, no routine dosage recommendations, and no contraindications formally established for patients outside clinical trials in everyday care.

    Based on current knowledge, the active ingredient continues to be studied for both efficacy and safety. As with other incretin-based medications, gastrointestinal symptoms, tolerability during dose escalation, and possible cardiometabolic effects may be relevant. Independent use or procurement should therefore not occur.

    Pregnancy and breastfeeding

    Retatrutide should not currently be used during pregnancy or while breastfeeding. Because the active ingredient has not yet been approved and remains in clinical development, patients planning a pregnancy should also rely on alternatives that are already approved and medically evaluated.

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    How does Retatrutide differ from other medications?

    The key difference lies not only in the active ingredient, but above all in the stage of development and the mechanism of action. Retatrutide is currently not an approved medication, but an active ingredient in clinical development. Based on current knowledge, retatrutide acts simultaneously on GIP, GLP-1, and glucagon receptors and therefore differs from currently available medications for weight loss or diabetes treatment.

    Currently available medications such as Wegovy, Mounjaro, or Ozempic are already approved and can be used in routine medical care. Retatrutide, by contrast, is still being studied in clinical trials and is not currently prescribed by The Body Clinic.

    Retatrutide vs. Wegovy

    Wegovy contains semaglutide and is approved in the European Union for weight management. Retatrutide, by contrast, has not yet been approved. There are also differences in mechanism of action: Wegovy acts as a GLP-1 receptor agonist, whereas retatrutide is being studied as a triple agonist acting on GIP, GLP-1, and glucagon receptors.

    Retatrutide vs. Mounjaro

    Mounjaro contains tirzepatide and acts on GIP and GLP-1 receptors. Based on current research, retatrutide goes one step further by also activating the glucagon receptor. Both active ingredients are being studied or used as once-weekly injections, but retatrutide remains an investigational drug and is not regularly available.

    Retatrutide vs. Ozempic

    Ozempic contains semaglutide and is primarily intended for the treatment of type 2 diabetes. Retatrutide is also being studied, among other things, in type 2 diabetes, but it has not yet been approved. Here too, the mechanism of action differs substantially, because Ozempic acts through GLP-1, whereas retatrutide is being developed as a triple agonist.

    Is Retatrutide covered by health insurance?

    Retatrutide is currently not approved and is not regularly available in Germany. For that reason alone, reimbursement in routine clinical care is not currently to be expected. Independently of this, medications used for weight loss, appetite suppression, or the regulation of body weight are generally excluded from statutory health insurance coverage in Germany.

    If you would like to learn more about currently available and actually prescribable options, you can find an overview on our page Prices for medical weight loss.

    How can I stop taking Retatrutide?

    Because retatrutide is currently not an approved medication for routine clinical use, there is no established everyday medical standard recommendation for stopping it, unlike with medications that are already approved. If retatrutide is being used as part of a clinical trial, any changes, pauses, or discontinuation should only take place after consultation with the responsible study team.

    It is also important to note that retatrutide should not be independently obtained or used outside regulated medical settings. If use has already taken place and there are symptoms, uncertainties, or questions about how to proceed, this should be discussed with a physician promptly. You can find an overview of currently available medically supervised programs under medical weight loss.

    Frequently asked questions about Retatrutide

    Retatrutide is currently not a regularly available medication. Lilly describes it as an investigational once-weekly triple hormone receptor agonist and states that it is not yet available for public use. The current EMA documentation relates to a pediatric investigation plan, not to a regular marketing authorization.
    Not as a regular treatment option. According to Lilly, retatrutide is currently legally available only within clinical trials and is not intended for the general market.
    Retatrutide is currently being studied, among other things, in obesity, type 2 diabetes, knee osteoarthritis pain, obstructive sleep apnea, chronic low back pain, and cardiovascular and renal outcomes.
    In clinical trials, retatrutide is administered as a once-weekly subcutaneous injection, meaning an injection under the skin. The EMA pediatric investigation plan for obesity also lists a solution for injection for subcutaneous use.
    Retatrutide is a triple agonist. It activates receptors for GIP, GLP-1, and glucagon at the same time. This three-part mechanism is what distinguishes retatrutide from classic GLP-1-based medications and also from dual agonists such as tirzepatide.
    Substantial weight reduction has been reported in studies. In the phase 2 trial in adults with obesity or overweight, higher-dose groups showed marked average weight loss after 48 weeks. However, study findings are not a fixed expectation for an individual patient and do not replace regulatory approval.
    So far, gastrointestinal side effects have been the main ones reported, especially nausea, vomiting, diarrhea, and constipation. In the phase 2 trial, additional dose-dependent adverse effects were also observed, which is one reason why safety and tolerability continue to be studied in phase 3.
    That cannot currently be answered in general terms. Retatrutide is not yet approved and is still being studied. For that reason, direct real-world comparisons with already approved medications such as semaglutide or tirzepatide are of limited value. The data on retatrutide are promising, but it remains part of clinical development.
    At present, regular reimbursement is not to be expected. Retatrutide is not currently available for public use. Independently of that, in Germany, medications used for weight loss, appetite suppression, or body weight regulation are generally excluded from statutory health insurance coverage.
    Because retatrutide is currently not an approved standard medication in routine care, there is no regular prescribing information for everyday use in Germany. If the drug is being used as part of a clinical trial, any changes or discontinuation should only be discussed with the responsible study team or a physician.

    Sources

    1. Jastreboff, A.M., Kaplan, L.M., Frías, J.P. et al. 2023. Triple-Hormone-Receptor Agonist Retatrutide for Obesity – A Phase 2 Trial. New England Journal of Medicine. Read study.
    2. Eli Lilly and Company. What to know about retatrutide. Open page.
    3. Eli Lilly and Company. Retatrutide: positive phase 3 results in obesity and knee osteoarthritis. Read press release.
    4. Eli Lilly and Company. Retatrutide: positive phase 3 results in type 2 diabetes. Read press release.
    5. ClinicalTrials.gov. A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1). Open trial registry.
    6. ClinicalTrials.gov. Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1). Open trial registry.
    7. European Medicines Agency (EMA). Retatrutide: Paediatric Investigation Plan (EMEA-003258-PIP02-23). Open EMA page.
    8. European Medicines Agency (EMA). Retatrutide: EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan. Open PDF.

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