Bioglutide (NA-931): Research & Studies

Research Overview#

Bioglutide (NA-931) has been evaluated in preclinical studies and two completed clinical trials (Phase 1 and Phase 2), with additional trials ongoing. The clinical evidence base is early-stage, consisting primarily of conference abstracts and press releases rather than full peer-reviewed journal publications. Despite limited data, the results to date suggest a potentially differentiated profile with meaningful weight loss, minimal GI side effects, and preservation of muscle mass.

The evidence level is classified as low based on the early stage of development, small sample sizes, short treatment durations, absence of peer-reviewed publications, and lack of head-to-head comparisons or cardiovascular outcomes data.

Preclinical Studies#

Diet-Induced Obese Mouse Models#

The initial preclinical evidence for NA-931 was presented at the International Conference on Obesity and Weight Management (October 2024, Las Vegas). In diet-induced obese (DIO) mouse models, NA-931 demonstrated:

• Body weight reduction up to 26% (P < 0.0001)
• Plasma glucose reduction of 23%
• Plasma triglyceride reduction of 34% (P < 0.003)
• Preservation of muscle mass during weight loss
• Lower incidence of adverse effects compared to existing therapies

These preclinical results supported the rationale for quadruple receptor agonism and provided the basis for clinical development.

Combination Preclinical Data#

Preclinical studies also evaluated the combination of NA-931 with tirzepatide, demonstrating synergistic effects on weight loss, blood glucose control, and lipid metabolism. These data formed the basis for the Phase 2 combination trial (NCT06732245).

Phase 1 Clinical Trial (NCT06615700)#

Study Design#

The Phase 1 study was a randomized, double-blind, placebo-controlled, multiple ascending dose trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of NA-931.

• Enrollment: 74 otherwise healthy overweight or obese adults (BMI 27 or greater), with or without type 2 diabetes
• Duration: 28 days of treatment with follow-up at Day 35
• Design: Multiple ascending dose escalation up to 150 mg daily oral capsule
• Primary endpoint: Safety and tolerability
• Secondary endpoints: Weight change, pharmacokinetics

Phase 1 Results#

The Phase 1 results were first reported in a press release (April 2025) and subsequently presented at scientific conferences:

Efficacy:

• Dose-dependent weight loss up to 6.4% of body weight at Day 28
• For doses of 60 mg and above, placebo-adjusted weight loss up to 5.3% was maintained or improved at Day 35 (7 days after the last dose)
• Up to 63% of NA-931-treated subjects achieved 5% or more weight loss, compared with 0% for placebo

Safety:

• All treatment-emergent adverse events were rated as insignificant or mild
• All observed GI adverse events were reported as insignificant or mild, with 84% rated as insignificant
• Notably, mild nausea and vomiting were not reported among any NA-931-treated subjects in Phase 1

Pharmacokinetics:

• Blood levels of NA-931 remained consistent regardless of fasting status or after a high-fat meal
• Pharmacokinetic profile supported once-daily dosing

Phase 1 Significance#

The Phase 1 results were remarkable for two reasons: the rapid onset of weight loss in only 28 days, and the near-absence of GI side effects that typically characterize GLP-1 receptor agonist therapy. The 6.4% weight loss in 28 days, if extrapolated (though extrapolation is inherently uncertain), suggested the potential for substantial weight reduction with longer treatment.

Phase 2 Clinical Trial (NCT06564753)#

Study Design#

The Phase 2 study was a 13-week randomized, double-blind, placebo-controlled, parallel-arm, multiple ascending dose trial.

• Enrollment: 125 adults with obesity (BMI 30 or greater) or overweight (BMI 27 or greater) with at least one weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease)
• Duration: 13 weeks
• Design: Parallel-arm with multiple dose levels, highest dose 150 mg daily
• Primary endpoint: Safety, tolerability, and weight change from baseline
• Trial ID: NCT06564753

Phase 2 Results#

Results were presented at three major conferences: ADA 2025 (June 2025, San Francisco), ENDO 2025 (July 2025, San Francisco), and EASD 2025 (September 2025, Vienna).

Weight Loss Efficacy:

• Maximum mean weight loss of 13.8% at the 150 mg daily dose
• Placebo-adjusted weight loss of 12.4% (some reports cite 11.9-13.2% depending on the placebo group calculation)
• 72% of NA-931-treated subjects achieved 12% or more weight loss, compared with approximately 2% for placebo
• Weight loss was dose-dependent across the tested dose range

Muscle Preservation:

• No muscle loss was observed during treatment, a finding attributed to IGF-1 receptor agonism
• This differentiates Bioglutide from existing GLP-1 agonists, where lean mass loss typically accounts for 25-40% of total weight lost

Safety and Tolerability:

• Treatment-emergent adverse events were predominantly insignificant or mild
• GI adverse events were reported as insignificant or mild, with 83% classified as insignificant
• Mild nausea and vomiting were reported in 7.3% of NA-931-treated subjects
• Diarrhea was reported in 6.3% of treated subjects
• No clinically meaningful differences were reported for GI-related adverse events among NA-931-treated subjects compared with placebo
• No serious adverse events were reported

Phase 2 Context and Interpretation#

The 13.8% weight loss at 13 weeks is notable when compared cross-trial to other anti-obesity agents:

While cross-trial comparisons are inherently limited by differences in patient populations, trial design, and duration, Bioglutide's 13.8% weight loss at only 13 weeks suggests that longer treatment could yield weight loss comparable to or potentially exceeding that of existing agents. Phase 3 trials with standard durations (52-72 weeks) will be needed to confirm this.

The GI tolerability profile is particularly noteworthy. For comparison, semaglutide 2.4 mg (Wegovy) causes nausea in 44% of patients, vomiting in 24%, and diarrhea in 30% in the STEP 1 trial. Bioglutide's rates of 7.3% nausea/vomiting and 6.3% diarrhea represent a substantially more favorable GI profile, if confirmed in larger trials.

Ongoing Clinical Trials#

Combination with Tirzepatide (NCT06732245)#

A Phase 2 study is evaluating the combination of NA-931 150 mg daily with tirzepatide in 224 adults with obesity or overweight with comorbidities. The trial is designed to assess:

• Whether the combination produces synergistic weight loss effects
• Whether NA-931 can reduce the GI adverse events associated with tirzepatide
• Whether IGF-1R activation can preserve or increase muscle mass during tirzepatide-induced weight loss
• Whether reduced tirzepatide doses can be used in combination without sacrificing efficacy

Planned Phase 3 Development#

Biomed Industries has announced plans for Phase 3 trials in both obesity and type 2 diabetes, though specific trial designs and timelines have not been disclosed as of early 2026.

Conference Presentations#

Evidence Quality Assessment#

Key Research Gaps#

1. Long-term efficacy and safety: No data beyond 13 weeks. Phase 3 trials with 52-72 week durations are essential.

2. Peer-reviewed publications: All data to date are from conference abstracts and press releases. Full peer-reviewed publications with complete methodology and statistics are needed.

3. Body composition quantification: While "no muscle loss" is reported, detailed body composition data (DEXA or equivalent) showing the proportion of fat versus lean mass change have not been published.

4. Cardiovascular outcomes: No CV outcomes data. Given the transformative impact of the SELECT trial for semaglutide, CV outcomes trials will eventually be needed.

5. Head-to-head comparisons: No direct comparisons with semaglutide, tirzepatide, or other approved agents.

6. Molecular characterization: Detailed structure, receptor binding affinities, and complete pharmacokinetic parameters have not been disclosed publicly.

7. Type 2 diabetes efficacy: While the Phase 1 included some diabetic patients, specific glycemic outcomes (HbA1c, fasting glucose) have not been reported.

8. Weight regain after discontinuation: No data on weight trajectory after stopping Bioglutide.

9. Special populations: No data in pediatric, elderly (over 75), or renally/hepatically impaired populations.

Related Reading#

• Bioglutide (NA-931) overview and research guide
• Bioglutide (NA-931) dosing protocols
• Bioglutide (NA-931) molecular structure