What Do AOD-9604 Studies Show in Humans and Animals?
Oral LAT8881, the same molecule as AOD-9604, missed its primary pain endpoint in 53 people (NCT03865953). Mean pain changed by -0.87 with LAT8881 and -0.74 with placebo. The net difference was -0.14, with a 95% interval from -0.76 to 0.49 and p = 0.67 (NCT03865953). Lateral Pharma sponsored the trial. A company-funded paper describes six earlier placebo-controlled trials but publishes no weight-loss result. These claims were checked 22 August 2026.
What did AOD-9604 do in human trials?
AOD-9604 also appears in trial registries as LAT8881. Three LAT8881 trials have posted results. All three tested pain rather than fat loss.
Neuropathic pain in 53 people
NCT03865953 was a randomized crossover phase 2 trial. It enrolled 53 people with nerve pain. Oral LAT8881 and placebo were each tested for four weeks. Lateral Pharma sponsored the trial.
Mean pain changed by -0.87 with LAT8881 and -0.74 with placebo. The net difference was -0.14. Its 95% interval ran from -0.76 to 0.49. The comparison was p = 0.67 (NCT03865953). The primary endpoint therefore did not show a significant difference.
No participant died. No participant in either group had a serious adverse event. Upper respiratory infection affected 3 of 51 people in each group. Headache affected 2 of 51 with LAT8881 and 4 of 51 with placebo (NCT03865953). These results were checked 22 August 2026.
Acute migraine in 21 people
NCT04153409 was a randomized crossover phase 2 trial in 21 people. Lateral Pharma sponsored it. The primary comparison used 16 LAT8881 periods and 17 placebo periods.
At 30 minutes, mean pain change was 0 with LAT8881 and 0.2 with placebo. The net difference was -0.02. Its 95% interval ran from -1.23 to 1.19. The comparison was p = 0.9733 (NCT04153409). The registry states that no adjustment for multiple comparisons was made.
Lumbar nerve-root pain in 26 people
NCT05298306 was a phase 1 trial with 26 actual participants. Lateral Pharma sponsored it. Its crossover pain analysis included 17 participants.
Pain change at 15 minutes was 3.7 with LAT8881 and 3.1 with placebo. The net difference was -0.25. Its 95% interval ran from -1.02 to 0.52. The comparison was p = 0.5196 (NCT05298306). Five of 17 people had an adverse event after LAT8881. Four of 17 had an event after placebo.
All three registry result sets were checked 22 August 2026. They are sponsored LAT8881 trials, not tests of a grey-market injection.
What did the six-trial human safety paper report?
Stier, Vos, and Kenley summarized six randomized, double-blind, placebo-controlled AOD-9604 trials (DOI 10.4021/jem157w). The six trials included 15, 23, 17, 36, 300, and 502 adults. The paper describes about 900 participants in total.
The two largest trials tested weight reduction in people with obesity. One followed 300 people for 12 weeks. The other followed 502 people for 24 weeks. The paper is a safety report. It does not publish their weight-loss results.
The paper reports no clinically relevant rise in IGF-1. It reports no negative effect on carbohydrate metabolism. It reports no detected anti-AOD-9604 antibodies. It reports no treatment-related withdrawal or serious adverse event across the six trials.
The highest research arm in a seven-day study had more gut-related adverse events. Five serious events occurred in the 12-week study. They were basal cell carcinoma, a moderate lipoma, squamous cell carcinoma, malignant melanoma, and breast cancer. The lead researcher judged none possibly, probably, or definitely related to the study drug.
Funding and interests: Metabolic Pharmaceuticals funded all six trials. Two authors worked for or consulted to Metabolic Pharmaceuticals. One held a 6.9% interest in its parent, Calzada. The writing company also consulted to Metabolic Pharmaceuticals. These facts were checked 22 August 2026.
Did human studies show weight loss from AOD-9604?
No published human weight-loss result was found in the opened sources and exact-name searches. This is not a claim that human obesity trials never happened. The safety paper identifies two large obesity trials, but does not report their efficacy outcomes.
The exact PubMed clinical-trial search for AOD9604, AOD-9604, or LAT8881 returned no indexed trial paper on 22 August 2026. The exact ClinicalTrials.gov search returned zero for AOD-9604 and three records for LAT8881. Those three records concern pain and are reported above.
What positive findings came from animal studies?
Animal work measured effects in three different models. None establishes the same result in a person.
In obese Zucker rats, oral AOD-9604 for 19 days cut body-weight gain by more than half (PMID 11146367). Mean gain was 15.8 g with AOD-9604 and 35.6 g in controls. Fat tissue showed greater lipolytic activity. The study found no adverse effect on insulin sensitivity. The PubMed record lists no grant support. Checked 22 August 2026.
In obese mice, 14 days of treatment reduced body weight and body fat (PMID 11713213). Long treatment failed to cause those changes in mice lacking the beta-3 adrenergic receptor. An acute test still increased energy use and fat oxidation in those knockout mice. The PubMed record lists no grant support. Checked 22 August 2026.
In 32 rabbits with induced knee osteoarthritis, AOD-9604 with hyaluronic acid produced lower tissue-damage scores than either treatment alone (PMID 26275694). The combined group also had a shorter period of lameness. The authors concluded that joint injections enhanced cartilage regeneration in this rabbit model. The PubMed record lists no grant support. Checked 22 August 2026.
What does one forum user report?
One Reddit user described using AOD-9604 together with tesofensine. The original Reddit thread was opened on 22 August 2026.
I've used them both and got basically nothing out of them.
This is one self-reported and self-selected account. It cannot separate the two compounds. No laboratory checked the products. No payment is disclosed in the post. The full thread is linked for context.
What has direct product analysis established?
A peer-reviewed paper is titled Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604 (PMID 24976118). The title establishes that a seized unknown preparation was analyzed as an AOD-9604 case.
The record has no abstract and the paper is not open. It does not let us state whether the preparation contained AOD-9604, its purity, its amount, or other contents. The PubMed record lists no grant support. These limits were checked 22 August 2026.
The vial-testing guide explains what a product analysis can and cannot establish.
What does EMA's central register show for AOD-9604?
EMA made its report on 22 August 2026. It held 2,731 medicine rows. No row matched AOD-9604, AOD9604, or hGH Fragment 176-191.
The search covers only EMA's central EU route. It does not cover national registers. AOD-9604's status in Europe therefore stays unclear. Checked 22 August 2026.
What does the FDA say about AOD-9604 compounding in the US?
For compounding in the US, the FDA's current page places AOD-9604 in its withdrawn-nominations table. It does not appear in the current Category 2 table. The American agency cites possible immune responses, peptide impurities, and problems identifying the exact compound.
The American FDA says it has little or no safety information for the proposed routes. It also says serious adverse events may be associated with AOD-9604 while noting that causality is unclear. This is the FDA's US risk statement. It is not another trial result.
These US status claims were checked 22 August 2026.
Primary FDA source in the US: current bulk-substance safety-risk page.
Where can a reader go next?
The training and recovery hub compares human, animal, and vial evidence. The AOD-9604 register record keeps evidence and status separate. The ipamorelin guide covers a different growth-hormone-axis compound.