Oral AOD9604 · adults with obesity · 12 weeks
The early trial reported −2.8 kg versus −0.8 kg
The sponsor’s original statistical appendix reports these adjusted mean changes from baseline. The primary comparison was not statistically significant: p = 0.10. [1]
A 2.0 kg numerical gap is not a confirmed treatment effect
The subtraction is straightforward: 2.8 minus 0.8 equals 2.0 kg. The uncertainty matters just as much. A numerical difference can favor treatment while the primary statistical test still fails to establish an advantage over placebo.
These are group averages. They do not show what every participant lost, the percentage of weight that was fat, or an expected outcome for someone using a vial, pen or nasal spray.
A secondary analysis using repeated measurements favored the 1 mg group and was statistically significant. The sponsor’s later clarification explains the two methods. That positive signal does not replace the nonsignificant primary endpoint. [5]
OPTIONS · oral tablets · diet and exercise in every group
The larger trial did not confirm a weight-loss advantage
OPTIONS enrolled 536 adults and randomized 502 after its run-in period. It compared oral 0.25, 0.5 and 1 mg/day with placebo. Neither the 12-week primary assessment nor the 24-week result established a statistically significant benefit. [2], [3]
Week 0: randomized treatment begins
All groups followed a diet-and-exercise program; the drug comparison was against placebo within that setting.
Week 12: endpoint not met
Weight changes did not establish an AOD9604 advantage over placebo.
Week 24: no confirmed advantage
The longer course did not resolve the efficacy finding. Obesity development was stopped.
Trial timing: original registry. Results: sponsor filing and FDA review. [2], [3], [4]
A fall in weight within a treatment group is not enough to establish that the peptide caused it. The relevant question is whether treatment improved the outcome beyond what occurred with the same background program and placebo. This trial did not establish that added benefit.
Visible changes and duration
Weight change does not specify a waist-size change
A scale measurement includes fat, lean tissue, water and other body mass. An average weight change cannot be converted into a particular waist reduction or a set of before-and-after photographs. The graphics on this page therefore show study measurements, not simulated patient transformations.
The research does not define a predictable visible change at one month. Nor does it establish how much weight loss the supplied formats would maintain after stopping. A scheduled follow-up visit is different from evidence of a durable treatment effect. [3], [4]
Vial · pen · spray
A product’s amount is measurable; its expected weight-loss result is not
5 mg vial
5,000 micrograms of listed powder content. The final concentration depends on a specified liquid volume.
View the vial →6 mg pen in 3 mL
2 mg/mL, or 2,000 micrograms/mL. A device setting requires the pen’s own delivery specification.
View the pen →10 mg spray
10,000 micrograms per bottle. Milligrams per bottle are different from micrograms delivered by one spray.
View the nasal spray →These conversions describe the products. They do not make an oral trial equivalent to subcutaneous or nasal use. The dosage and calculator page keeps concentration, delivered amount and package totals separate.
Original records
Sources for the measured results
- Metabolic Pharmaceuticals (December 13, 2004): 12-week trial results. Statistical appendix, page 6; original sponsor report.
- Metabolic Pharmaceuticals (February 21, 2007): original OPTIONS results. PDF pages 6–10, including the randomized-participant table.
- FDA (2024): scientific review of AOD9604. Clinical-effectiveness analysis and limitations.
- ANZCTR: OPTIONS trial registration, ACTRN12605000067673. Route, dose groups and planned assessment times.
- Metabolic Pharmaceuticals (December 17, 2004): explanation of the two statistical analyses. Original sponsor clarification.
Compare the three formats, supplied photographs and available certificate.
Compare AOD9604 products →
