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Key takeaways
Trulicity (dulaglutide) is FDA-approved for treating Type 2 diabetes and reducing cardiovascular mortality.
Despite not being FDA-approved for weight loss, Trulicity is sometimes prescribed off-label for this purpose. When taken at higher doses, it’s particularly effective in patients with a higher BMI.
Trulicity mimics incretin hormones that slow gastric emptying and increase satiety, leading to potential weight loss in patients.
Alternatives like Ozempic (semaglutide) and Mounjaro have been compared to Trulicity. They show varying degrees of effectiveness in blood glucose control and weight loss.
Trulicity (dulaglutide) is a prescription antidiabetic injectable medication that belongs to a class of drugs known as glucagon-like peptide-1 receptor agonists (GLP-1).GLP-1 receptor agonists have been shown to lower hemoglobin A1C, an indicator of long-term blood glucose control, by up to 1.6%. Other biological effects of GLP-1 receptor agonists related to the treatment of Type 2 Diabetes Mellitus include improved insulin sensitivity, decreased glucagon concentrations, delayed gastric emptying, increased satiety (feeling of fullness), and decreased body weight. Not all GLP-1 medications have approval from the U.S. Food and Drug Administration (FDA) to be used for weight loss, but many will still be used off-label, or without approval, to help with weight loss. Trulicity is officially approved for the treatment of Type 2 diabetes in combination with diet and exercise and for the reduction of cardiovascular mortality. The big question is—is there any evidence that Trulicity is effective for weight loss, and can your doctor prescribe it for weight loss?
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Not every GLP-1 receptor agonist has sought approval from the FDA to list weight loss as an indication. Despite this, many healthcare professionals will prescribe them for weight loss, making this use “off-label.” Off-label use refers to utilizing a drug for a purpose not approved by the FDA. Trulicity is officially approved for the treatment of Type 2 diabetes in combination with diet and exercise and for the reduction of cardiovascular mortality. The big question is—is there any evidence that Trulicity is effective for weight loss?
What is Trulicity used for?
Eli Lilly and Company is the manufacturer of Trulicity. Trulicity is approved by the Food and Drug Administration (FDA) for two specific indications. The first is treating Type 2 diabetes mellitus as an adjunct to diet and exercise. The second indication is reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus with established cardiovascular disease or multiple cardiovascular risk factors. You may have seen reports of Trulicity being used for weight loss. This indication is not approved by the FDA, even though use for this purpose may be relatively common. This is an example of off-label use.
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How does Trulicity work for weight loss?
Trulicity and other GLP-1 receptor agonists were designed to mimic the structure of naturally occurring hormones in the human body known as incretin hormones. When you eat food, your stomach releases these hormones, which, in turn, stimulate insulin release from the pancreas. Insulin helps control blood sugar levels by helping cells absorb glucose for energy. Type 2 diabetes patients often lack enough incretin hormones to stimulate this process, which is why the GLP-1 receptor agonists are effective at helping them manage their blood sugar.
So how does this mechanism help with weight loss? Incretin hormones, along with the chemically similar GLP-1 receptor agonists, slow gut motility and, therefore, slow the emptying of the gastrointestinal tract. This leads to food remaining in the intestinal tract longer and, therefore, increased and prolonged feelings of satiety, or feeling full. The feeling of being full leads to appetite suppression, which is thought to be the primary way GLP-1 receptor agonists like Trulicity aid with weight loss.
Lilly USA, the makers of Trulicity, reported the results of a 36-week observation of patients with a BMI greater than or less than 33.2 or higher. Doses of Trulicity 1.5 mg, 3.0 mg, and 4.5 mg were evaluated. Patients with higher BMI taking higher doses of Trulicity experienced the most weight loss as measured in pounds lost from baseline. The average weight loss from the highest Trulicity dose of 4.5 mg was 10.1 pounds.
The results of the AWARD-11 trial concur that weight loss occurs most frequently in patients with the highest starting BMI on the highest doses of Trulicity. While most patients do lose some weight, there is a chance they will not lose weight or may even gain weight. Other factors, such as diet and exercise, will affect weight loss success.
Do doctors prescribe Trulicity for weight loss?
While some GLP-1 receptor antagonists are approved by the FDA for weight loss, Trulicity is not. Saxenda (liraglutide), Ozempic (semaglutide), and Wegovy (semaglutide) do have approval to be used in weight loss. Most recently, Zepbound (tirzepatide) has been added to the list of approved GLP-1 drugs for weight loss. Zepbound is unique, however, because it is a combination GLP-1 with a glucose-dependent insulinotropic peptide (GIP). This dual mechanism has provided superior weight loss results in many patients as compared to the first GLP-1 drugs. While Trulicity does not have FDA approval for weight loss, some prescribers may still prescribe it and see weight loss results in their patients.
AWARD-11 was a randomized, controlled trial that evaluated the efficacy and safety of Trulicity at multiple doses. This trial was all Type 2 diabetes patients. Patient results were divided by BMI and Trulicity dose. In the reporting, patients with the highest BMIs (the most overweight) taking the highest dose of Trulicity (4.5 mg) experienced the most weight loss.
Trulicity is only approved to be used in Type 2 diabetes mellitus patients. Many Type 2 diabetes patients also suffer from obesity. If you do not have diabetes and take Trulicity, there could be serious side effects and adverse events related to hypoglycemia or low blood glucose levels. It can make you shaky, lower your blood pressure too much, or even make you unconscious. If you are diabetic and taking Trulicity, you may experience weight loss, and that is okay as long as your healthcare provider monitors the appropriate parameters. Giving Trulicity only for weight loss, especially in a non-diabetic, should not be done.
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There are some considerations before your doctor can decide if Trulicity for weight loss is appropriate. If you have ever had an allergic reaction to Trulicity, you should not repeat the treatment. If you have a history of thyroid cancer (specifically medullary thyroid carcinoma) or multiple endocrine neoplasia, the use of Trulicity is contraindicated as well. Severe abdominal pain when taking Trulicity should be evaluated as it could be linked to pancreatitis. Trulicity has been linked to dangerously low blood sugar levels, though this is rare. More common side effects of Trulicity include nausea and diarrhea.
RELATED: Trulicity dosage
How long does it take for Trulicity to work?
The amount of weight you may lose while taking Trulicity appears to be primarily dependent upon your body mass index (BMI) and the dose of Trulicity you are prescribed. In the AWARD 11 trial, diabetic patients with a higher BMI taking higher doses of Trulicity saw the highest amount of weight loss. How quickly you lose weight will depend on your adherence to the medication, your starting BMI, your dose, as well as your diet and exercise plan.
Trulicity dosage for weight loss
The manufacturer of Trulicity reported its findings for weight loss after following patients from baseline, or day zero, to 36 weeks. The following table shows the average weight loss at each dose of Trulicity:
Trulicity dosage for weight loss |
|
|---|---|
| Dosage | Average weight loss |
| Trulicity 1.5 mg | 6.6 lbs |
| Trulicity 3.0 mg | 8.4 lbs |
| Trulicity 4.5 mg | 10.1 lbs |
It is important to note that the manufacturer also makes it clear that some patients will lose no weight at all while taking Trulicity. The amount of weight lost on average is meaningful. However, it is not necessarily a quick reduction in weight. Patients could lose the same amount or more safely with a comprehensive diet and exercise program. For diabetic patients, diet and exercise must be a component of the treatment plan.
Other diabetic medications that cause weight loss
Trulicity is not an FDA-approved weight loss drug. Type 2 diabetes mellitus patients taking Trulicity to lower their blood sugar may also benefit from some weight loss while taking Trulicity. Patients who are not diabetic should not take Trulicity.
Other GLP-1 receptor agonists have been shown to cause weight loss as well. Ozempic (semaglutide) is approved with an indication for weight loss. The SUSTAIN 7 clinical trial showed Ozempic to be superior to Trulicity, leading to twice as much weight loss.
Victoza (liraglutide) was compared to Trulicity in the AWARD 6 trial, and the study found that the weight loss associated with Victoza was significantly better than that associated with Trulicity. We would expect this because Saxenda, another branded product of liraglutide, is marketed and approved for weight loss.
Metformin, a prescription diabetes drug in the sulfonylureas class, is typically the first-line treatment for Type 2 diabetics and has also been linked to weight loss, though it is not approved for it. The AWARD 3 trial showed similar rates of weight loss between Trulicity and metformin-treated patients. The most recent development in the weight loss drug category is Zepbound (tirzepatide). The tirzepatide compound first came to market under the name Mounjaro, and it is a glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 in one single molecule. Mounjaro’s FDA approval was for diabetes only, and Zepbound came to market later with approval for weight loss. Zepboundo, like many GLP-1 drugs, has multiple dosing intervals. At its highest dose, patients may see up to 25 pounds of weight loss at the 40-week mark. This is significantly more than any other drug in a similar category. Zepbound shows superior blood glucose control and weight loss compared to Trulicity. This drug has had such an impact on the market that there have been periods of wholesale availability challenges where your local pharmacy may have had difficulty getting the medication in stock for you.
You should not use any of these drugs for weight loss without the medical advice of your healthcare provider.
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How to maximize Trulicity benefits
Trulicity is a once-weekly diabetes medication also approved to lower cardiovascular risk. It should not be given more often than once every seven days. It can be given at any time of the day without regard to meals. Do not mix Trulicity with other drugs, such as insulin. Each pen is labeled with the dose and is for single use only. Trulicity should be stored in the refrigerator, but it can be removed for a short period of time before the injection to allow it to come to room temperature and be a less painful injection.
Trulicity does not interact with grapefruit or grapefruit juice. It is also safe to consume caffeine in normal amounts. While alcohol is not contraindicated with Trulicity, it can increase the likelihood of stomach upset, diarrhea, or vomiting. Alcohol should be consumed responsibly and in limited amounts.
A healthy diet and regular exercise aid weight loss with any drug. Your healthcare provider can direct you to other resources to take charge of your diet and exercise routines.
Sources
- Glucagon-Like Peptide 1 Receptor Agonists for Type 2 Diabetes, Diabetes Spectr (2017)
- Trulicity, www.trulicity.com (2024)
- AWARD-11 Trial, Diabetes Care (2021)
- Beyond glycemia: Comparing tirzepatide to GLP-1 analogues, Rev Endocr Metab Disord (2023)
- Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial Lancet Diabetes Endocrinol (2018)
- Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3) Diabetes Care (2018)
- Mounjaro, www.mounjaro.com (2024)
