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GIP/GLP-1/glucagon receptor triple agonist (investigational)

Retatrutide for Women: Investigational Status

Medically reviewed by Editorial Medical Review, MD, NAMS-CMP · Updated July 2026

Quick answer

Retatrutide is an investigational triple-hormone agonist (GIP, GLP-1, and glucagon) being studied for weight management. It is not FDA-approved and is not commercially available. In a phase 2 trial, participants lost up to about 24% of body weight at 48 weeks. Pregnancy and contraception data specific to women are limited.

How it works

Retatrutide activates three receptors, GIP, GLP-1, and glucagon, combining appetite reduction with increased energy expenditure. In a phase 2 NEJM trial, the highest dose produced roughly 24% mean weight loss at 48 weeks. Phase 3 trials are ongoing.

FDA status for weight: Not FDA-approved and not available by prescription. Retatrutide is investigational; its efficacy and safety are still being evaluated in clinical trials.

Women-specific considerations

These are factual notes from FDA labels and published guidelines, not personal medical advice. Discuss your situation with a licensed clinician.

No label guidance yet

Because retatrutide is not approved, there is no FDA label guidance for women on pregnancy, breastfeeding, or contraception. Clinical-trial protocols typically require effective contraception for participants.

Online products are not the drug

Any product sold online as retatrutide is not an FDA-approved medicine. The FDA has warned about unapproved GLP-1-type products outside the regulated supply chain.

No PCOS or menopause approvals

There are no approvals for retatrutide in PCOS, perimenopause, or any indication. It can only be accessed through a registered clinical trial.

Who it is for (eligibility)

There is no FDA eligibility because retatrutide is not approved. Access is limited to enrollment in a registered clinical trial evaluating the drug.

Cost (cited)

Not commercially available

Pricing varies (investigational)

ClinicalTrials.gov — retatrutide phase 3 program

Related questions

Frequently asked questions

Can I get retatrutide now?
No. Retatrutide is investigational and not FDA-approved, so it is only available through registered clinical trials. Products sold online as retatrutide are unapproved and not verified medicines.
How much weight did people lose on retatrutide?
In a phase 2 NEJM trial, participants on the highest dose lost up to about 24% of body weight at 48 weeks. These are early-phase results; phase 3 trials are still underway.
Is retatrutide safe during pregnancy?
This is unknown. Retatrutide is not approved and has no label guidance, and clinical trials generally require effective contraception for participants.

Sources

Every claim above resolves to an FDA label, published trial, guideline, or manufacturer / GoodRx pricing page. External links open in a new tab.

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ClearHormones updates this explainer as FDA status and pricing change. Verify current approval status and pricing on the manufacturer or FDA page before acting.