Dulaglutide

FDA-approved (prescription) Evidence grade A — regulator-approved with pivotal randomised trials Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: Trulicity.

Regulatory status

FDA-approved (initial US approval 2014) as Trulicity for type 2 diabetes in adults and children 10+, and for MACE reduction in adults with type 2 diabetes and CV disease or risk factors [1]. Not approved for weight management. Prescription only.

What it is

GLP-1 receptor agonist (fusion protein: two GLP-1 analogue chains linked to the Fc portion of a modified human immunoglobulin; 90 % homology to GLP-1(7-37)).

A once-weekly injected GLP-1 receptor agonist. Approved in the US for glycaemic control in type 2 diabetes (adults and children 10+) and to lower the risk of major cardiovascular events in adults with type 2 diabetes.

What the published research shows

Phase 3 RCTs including AWARD-11 (1,842 patients on higher doses); REWIND outcomes trial randomised 9,901 patients, median follow-up 5.4 years.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Type 2 diabetes, adults (Trulicity label): Label: 0.75 mg subcutaneously once weekly to start; after 4 weeks may go to 1.5 mg weekly, then up in 1.5 mg steps (3 mg, 4.5 mg) after at least 4 weeks on each dose; label maximum 4.5 mg weekly.
Type 2 diabetes, children 10+ (Trulicity label): Label: 0.75 mg once weekly; may go to a label maximum of 1.5 mg weekly after at least 4 weeks.
Higher doses in type 2 diabetes on metformin (AWARD-11 trial): 1,842 patients; at 36 weeks HbA1c fell 1.77 % with 4.5 mg versus 1.54 % with 1.5 mg, and weight fell 4.6 kg versus 3.0 kg (treatment-regimen estimand).
Cardiovascular outcomes in type 2 diabetes (REWIND trial): Dulaglutide 1.5 mg weekly in 9,901 patients, median 5.4 years: primary MACE outcome in 12.0 % versus 13.4 % with placebo (hazard ratio 0.88).

Mechanism, as reported

Activates the GLP-1 receptor, raising glucose-dependent insulin release, lowering glucagon and slowing gastric emptying. Fusion to an antibody Fc fragment makes the molecule large and slowly cleared, which allows weekly dosing.

Practical record

Elimination half-life: 120.0 h (confidence: high). Label: elimination half-life approximately 5 days; Tmax 24-72 h (median 48 h); steady state in 2-4 weeks; SC bioavailability 65 % (0.75 mg) and 47 % (1.5 mg); clearance 0.142 L/h. Apparent central volume of distribution 3.09 L and peripheral 5.98 L (about 9.1 L total) in both the US label and the EMA SmPC; the app uses that total.
Studied routes: subcutaneous.
Typical supply: Single-dose pens 0.75, 1.5, 3 and 4.5 mg per 0.5 mL (Rx).
Reconstitution: Supplied as a ready solution; not reconstituted.
Storage: Refrigerate 2-8 °C; each pen may be kept at room temperature up to 30 °C for a total of 14 days; do not freeze or use if frozen.

Safety signals on record

Reported adverse events: Most common: nausea, diarrhoea, vomiting, abdominal pain and decreased appetite; also small heart-rate increases, PR-interval prolongation, raised pancreatic enzymes and, with insulin or sulfonylureas, hypoglycaemia.
Contraindications: Boxed warning for thyroid C-cell tumours in rats: contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2, and after a serious hypersensitivity reaction to dulaglutide. Warnings for pancreatitis, hypoglycaemia with secretagogues/insulin, hypersensitivity, acute kidney injury from dehydration, severe GI reactions, diabetic retinopathy complications, gallbladder disease and aspiration under anaesthesia.
Interactions: Slows gastric emptying: monitor drug levels of narrow-therapeutic-index oral drugs such as warfarin; insulin secretagogue or insulin doses may need lowering.
Notes: In REWIND, gastrointestinal adverse events were reported by 47.4 % on dulaglutide versus 34.1 % on placebo.

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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