Tesamorelin + Ipamorelin Blend

Also known as: Tesa/Ipa, Visceral Fat Blend, Premium GH Stack

Evidence: Preclinical

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Overview

Vial blend of tesamorelin and ipamorelin (vendors sell 6/2 mg and 10/3 mg); tesamorelin cut visceral fat in HIV phase 3 trials, and no study has tested the pair.

Tesamorelin is approved by FDA as Egrifta (2010) for excess abdominal fat in HIV lipodystrophy; this research blend is not that product. Vendors mix tesamorelin and ipamorelin at about 3:1, as 8 mg (6/2 mg) or 13 mg (10/3 mg) vials. In two phase 3 RCTs (n=806), tesamorelin 2 mg daily cut visceral fat about 15% versus placebo over 26 weeks, and the effect was lost after stopping (Falutz 2010). Ipamorelin has one human PK study and one negative phase 2 trial in postoperative ileus (Beck 2014). GHRH-class and GHRP-class peptides were synergistic for GH release in men (Bowers 1990), the rationale for the pairing, but no study has tested tesamorelin with ipamorelin, and the trial results apply to tesamorelin alone in HIV. FDA lists ipamorelin in category 2 for 503B outsourcing on its compounding safety-risk page.

Benefits

Visceral fat reduction (human RCTs, tesamorelin in HIV lipodystrophy); GH pulse after IV ipamorelin (human PK study); combined effect untested. No data for the blend

Dosing reference

Research dose: 1 to 2 mg of blend daily (about 0.75 to 1.5 mg tesamorelin and 0.25 to 0.5 mg ipamorelin at the 6/2 mg ratio): vendor/community range, no published human dose of the blend. The approved tesamorelin product is labelled at 1.28 to 2 mg daily
Range: 1000 to 2000 mcg, 1x daily before bed
Reconstitution: 2 mL bacteriostatic water
Common vial sizes: 8 mg, 13 mg

Subcutaneous once daily in community use, often at bedtime. Egrifta labels give tesamorelin 1.28 to 2 mg SC once daily depending on presentation, and the phase 3 trials used 2 mg daily; those doses apply to the approved product, not this blend. Visceral fat returned after tesamorelin was stopped (Falutz 2010). Human ipamorelin doses were IV (0.03 mg/kg twice daily in the ileus trial).

Mechanism

Proposed, from component and class studies. Tesamorelin is GHRH(1-44) with a trans-3-hexenoic acid group on its N-terminus that resists breakdown; it acts on the pituitary GHRH receptor and raised IGF-1 81% in a phase 3 trial (Falutz 2007). Its visceral-fat effect is attributed to the GH rise. Ipamorelin is a ghrelin-receptor agonist that released GH without raising ACTH or cortisol in swine (Raun 1998). GHRH-receptor and ghrelin-receptor agonists given together raise GH more than either alone in men (Bowers 1990), shown with other analogs. Whether adding ipamorelin changes tesamorelin's visceral-fat or glucose effects has not been studied.

Evidence

Preclinical: animal or in vitro data only

Phase 3 RCT, n=412: tesamorelin 2 mg daily cut visceral fat 15.2% vs a 5.0% rise on placebo over 26 weeks in HIV lipodystrophy (Falutz et al., 2007)
Pooled phase 3, n=806: visceral fat treatment effect -15.4%, kept to 52 weeks and lost after switching to placebo (Falutz et al., 2010)
RCT, n=50: tesamorelin reduced visceral and liver fat over 6 months, with a transient fasting glucose rise at 2 weeks (Stanley et al., 2014)
Phase 2 RCT of IV ipamorelin in postoperative ileus (n=114): well tolerated, no efficacy difference from placebo (Beck et al., 2014)
Human-trial status: no study has tested the blend as sold. Tesamorelin was approved in 2010 (Egrifta) for HIV-associated abdominal fat only; ipamorelin's only RCT was negative, and GHRH plus GHRP synergy in men was shown with other analogs (Bowers et al., 1990)

References

Side effects

No human safety study of the blend has been published. On the Egrifta labels the most common tesamorelin adverse reactions (over 5%) were joint pain, injection-site redness and itching, pain in the limbs, peripheral edema and muscle pain; one small RCT saw a transient fasting-glucose rise (Stanley 2014). IV ipamorelin was well tolerated in a phase 2 trial (Beck 2014). Label contraindications for tesamorelin include active malignancy, disruption of the hypothalamic-pituitary axis and pregnancy. Ipamorelin is in category 2 of FDA's 503B interim policy (added 2023-09-29) and in the withdrawn-nomination table for 503A, as of 2026-04-22: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks.

Storage

Storage: Refrigerate 2-8°C (36-46°F)
Lyophilized: 2+ years at room temp, 3+ years refrigerated
Reconstituted: 28-30 days refrigerated

Pharmacology

Half-life: Tesamorelin ~8 to 11 min (human, SC; current Egrifta SV and WR labels). Ipamorelin ~2 h terminal (human, IV)
Bioavailability: Tesamorelin SC under 4% (human; Egrifta SV label). Ipamorelin human data are IV. No data for the blend