AOD-9604

Also known as · hGH fragment 176-191 analogue · METAOD programme (Metabolic Pharmaceuticals)

01 / Dosing schedule

Cited dosing

AOD-9604's pivotal human evidence is the phase 2b OPTIONS obesity trial, and critically it was an oral tablet programme, not the injectable protocol sold online. Dose groups were 0.25 mg, 0.5 mg and 1 mg once daily versus placebo; the trial did not beat placebo and development stopped.

AOD9604 phase 2b OPTIONS obesity trial — oral, once daily

PhaseDose & frequency
Dose groups0, 0.25, 0.5 and 1 mg (0 = placebo)
Routeoral tablets
Frequencyonce per day
Primary endpointweight loss at 12 weeks vs placebo
Randomised treatment period24 weeks double-blind; full protocol 32 weeks
Population536 subjects, BMI 30-45 kg/m2, age 18-65, waist >102 cm (men) / >95 cm (women)
Injectable subcutaneous dosen.a. — no injectable AOD-9604 dose was confirmed from a primary source in this session

Source · Metabolic Pharmaceuticals. Obesity Trial Update: First 100 Subjects Complete The Phase 2B (OPTIONS) Trial Of AOD9604 (press release, via BioSpace). ↗

Source indication · Obesity: 536 subjects with BMI 30-45 kg/m2, aged 18-65 (Metabolic Pharmaceuticals phase 2b 'OPTIONS' study)

Injection frequency
Once daily, oral, for 24 weeks of randomised treatment within a 32-week protocol.
Injection sites
Not applicable — the phase 2b programme was an oral tablet, so no injection site exists in the trial record.

02 / Reconstitution

Reconstitution reference

Not applicable: the phase 2b trial used tablets. Any subcutaneous reconstitution scheme for AOD-9604 has no basis in the trial documentation fetched here.

Vialn.a. — oral tablet in the phase 2b trial
BAC watern.a.
Concentrationn.a.
Example dose1 mg once daily (highest oral phase 2b dose)
On a U‑100 syringeoral tablet
Open the reconstitution calculator →

03 / Overview

Protocol overview

AOD-9604 is a modified C-terminal fragment of human growth hormone (residues 176-191) developed by Metabolic Pharmaceuticals in Australia as an anti-obesity agent. It reached phase 2b and then stopped; it has never been approved anywhere as a weight-loss drug.

The pivotal study, called OPTIONS, enrolled 536 subjects with BMI 30-45 kg/m2 and elevated waist circumference. It randomised them to oral AOD9604 0.25 mg, 0.5 mg or 1 mg once daily, or matching placebo tablets, with weight loss at 12 weeks as the primary endpoint within a 24-week double-blind period.

The single most important honesty point for a dosing page: the milligram amounts that survive in the literature are oral once-daily tablet doses under 1 mg. They are not subcutaneous doses, and the sponsor's own release describes the route as 'oral (tablets)'.

No human elimination half-life and no injection site could be confirmed from a primary source in this session, so both are recorded as n.a. The trial ultimately failed to demonstrate efficacy versus placebo, which is why the programme did not advance to phase 3.

04 / References

References

  1. Metabolic Pharmaceuticals phase 2b OPTIONS trial update for AOD9604 (BioSpace) ↗
  2. Peptide submission to FDA docket FDA-2024-N-4777 discussing AOD9604 (no human dose amounts stated in the document) ↗