This is the second installment of our monthly blog series on the latest developments in metabolic medicine. Evidence based, practical, and easy to understand.
“Am I even a good candidate for this therapy?” I hear this question every day in my clinic. The answer is not always straightforward. While GLP 1 receptor agonists are officially approved for certain indications, current studies also show promising results in other conditions. Let’s take a closer look at what is officially approved and what is considered off label use.
Official approvals in Germany and the EU
GLP 1 receptor agonists such as semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro) are approved in Germany and the EU for the following indications:
1. Type 2 diabetes mellitus
The original approvals were for the treatment of type 2 diabetes. These medications improve glycemic control, lower HbA1c, and reduce the risk of diabetes related complications.
Evidence: The SUSTAIN and PIONEER trials for semaglutide, and the SURPASS trials for tirzepatide, showed HbA1c reductions of about 1.5 to 2.5 percentage points, which is more than many other diabetes medications.
2. Obesity (weight management)
Since 2022, semaglutide (Wegovy) has been approved at a higher dose for weight reduction, with the following criteria:
- BMI of at least 30 kg/m² (obesity)
- or BMI of at least 27 kg/m² with at least one weight related comorbidity
Which comorbidities count?
- Type 2 diabetes or prediabetes
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
Evidence: The STEP trials with semaglutide showed an average weight loss of about 15 percent. The SURMOUNT trials with tirzepatide showed weight loss of up to 22.5 percent (Jastreboff et al., NEJM 2022, PMID: 35658024).
3. Cardiovascular risk reduction
The SELECT trial led to an expanded approval in 2023: semaglutide reduces the risk of heart attack, stroke, and cardiovascular death by 20 percent in patients with overweight and established cardiovascular disease, regardless of whether they have diabetes (Lincoff et al., NEJM 2023, PMID: 37952131).
What does off label use mean?
Off label use means a medication is used outside its official approval, meaning for conditions or patient groups for which it is not yet approved. In Germany, this can be legally permissible if:
- There is no approved alternative
- The treatment is medically reasonable
- Clinical data suggest effectiveness
- Patients are thoroughly informed
Important: With off label use, statutory health insurance usually does not cover the costs. Treatment typically must be paid out of pocket.
PCOS: new hope for women with polycystic ovary syndrome
Polycystic ovary syndrome (PCOS) affects about 10 to 15 percent of women of reproductive age. It is characterized by insulin resistance, excess weight, irregular cycles, and elevated androgens (hyperandrogenism).
Current evidence for GLP 1 therapy in PCOS
Several randomized controlled trials show promising results:
- Weight loss: Women with PCOS treated with liraglutide (3.0 mg) lost an average of 5 to 10 percent of body weight, significantly more than with placebo or metformin alone.
- Improved insulin resistance: HOMA IR (a marker of insulin resistance) improved by about 30 to 40 percent.
- Hormonal effects: Testosterone levels decreased by about 15 to 25 percent, which was associated with less acne, hair loss, and unwanted hair growth.
- Ovulation and fertility: In a study of 72 women, ovulation rates improved by 50 percent with liraglutide compared with metformin (Jensterle et al., Eur J Endocrinol 2015).
- Combination with metformin: Combining a GLP 1 receptor agonist with metformin appears especially effective and may outperform either therapy alone.
What does this mean for patients?
GLP 1 receptor agonists are not officially approved for PCOS, so this is off label use. However, treatment may be reasonable when:
- Excess weight and insulin resistance are the main issues
- Metformin alone is not sufficiently effective
- There is a desire to conceive (important: discontinue if pregnancy occurs)
- Cost coverage is clarified in advance, since it is usually self pay
Other off label uses
Prediabetes
Prediabetes (HbA1c 5.7 to 6.4 percent or fasting glucose 100 to 125 mg/dl) is a precursor to type 2 diabetes. Studies suggest GLP 1 receptor agonists can reduce progression to diabetes by up to 60 percent. Off label use may be considered for prevention in selected cases.
Metabolic syndrome
The combination of excess weight, high blood pressure, elevated lipids, and insulin resistance often responds well to GLP 1 therapy, even if diabetes has not yet developed.
Fatty liver disease (NASH or MASH)
As described in our first blog post, GLP 1 receptor agonists show impressive effects on the liver. Official approval for NASH is expected, but at present this remains off label use.
Cost coverage: when will insurance pay?
Cost coverage likely
- Type 2 diabetes with obesity (BMI at least 30)
- Type 2 diabetes with inadequate glycemic control
- Obesity (BMI at least 30) after unsuccessful weight loss attempts
Cost coverage unlikely
- Overweight without diabetes (BMI 27 to 29.9)
- PCOS without diabetes
- Prediabetes
- Weight loss only without comorbidities
- Off label indications
Self pay options
If insurance does not cover treatment, self pay remains an option.
Tip: Some private insurers may cover costs when there is a clear medical indication. Submitting a request with a physician’s justification can be worthwhile.
Legal and ethical considerations
As a physician, I believe it is essential to communicate transparently:
- Off label use is legal and often medically reasonable
- The evidence must justify the approach
- Thorough informed consent is required
- Statutory health insurance typically does not cover costs
- Regular follow ups are necessary
Conclusion: an individualized decision with medical guidance
The question “Am I a good candidate?” cannot be answered in a one size fits all way. While official approvals define clear criteria, studies also show promising results for other conditions such as PCOS, prediabetes, or metabolic syndrome.
My recommendation:
- Schedule a comprehensive consultation
- Have your individual situation evaluated
- Clarify cost coverage in advance
- Make the decision together with your clinician
In the next blog post (January 2026), we will focus on what treatment looks like in practice and how to manage side effects, so you can start therapy as prepared as possible.
Scientific references
- Obesity trials: Jastreboff AM, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022. DOI: 10.1056/NEJMoa2206038, PMID: 35658024
- Cardiovascular risk reduction: Lincoff AM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023. DOI: 10.1056/NEJMoa2307563, PMID: 37952131
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PCOS: Jensterle M, et al. Metformin and liraglutide exert additive effect on body weight loss in obese women with PCOS. Eur J Endocrinol. 2015.
Elkind Hirsch K, et al. Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008. - Systematic reviews: Jensterle M, et al. The role of glucagon like peptide 1 receptor agonists in the management of polycystic ovary syndrome: a systematic review. Diabetes Obes Metab. 2019.
Important: This article is for informational purposes only and does not replace individualized medical advice. Please talk with your physician about whether this type of therapy is appropriate for you.
Do you have questions about your individual situation?
Schedule a consultation appointment at The Body Clinic. We will take the time you need and work with you to find the best solution for your health.